FDA.reportPublic FDA data

Isabelle Lang-Zwosta

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80316732967Isabelle Lang-Zwosta1N2026-01-013600 Gantz Rd Grove City OH US 43123
96123163002808328Isabelle Lang-Zwosta1N2026-01-013600 Gantz Rd Grove City OH US 43123
30045290193004529019Isabelle Lang-Zwosta1N2026-01-013600 Gantz Rd Grove City OH US 43123

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
109861234347852P910065AIA-PACK PSAMTF1993-07-07
109881234347852P910065AIA-PACK PSAMTF1993-07-07
109881736316252K992365AIA-PACK FOLATE ASSAYCGN1999-08-10
109861736316252K992365AIA-PACK FOLATE ASSAYCGN1999-08-10
109881372077778K991252AIA-PACK FT3 ASSAYCDP1999-05-11
109861372077778K991252AIA-PACK FT3 ASSAYCDP1999-05-11
109881418772801K981522AIA-PACK TGAB ASSAYJZO1998-10-08
109861418772801K981522AIA-PACK TGAB ASSAYJZO1998-10-08
109881787011769K981521AIA-PACK TPOAB ASSAYJZO1998-10-08
109861787011769K981521AIA-PACK TPOAB ASSAYJZO1998-10-08
109881169143222K981012AIA-PACK MYOGLOBIN ASSAYDDR1998-05-28
109861169143222K981012AIA-PACK MYOGLOBIN ASSAYDDR1998-05-28
109881304853235K972697AIA-PACK IGE II ASSAYDGC1997-10-03
109861304853235K972697AIA-PACK IGE II ASSAYDGC1997-10-03
109861798506618K972586AIA-PACK TSH 3RD-GEN ASSAYJLW1997-08-29
109881798506618K972586AIA-PACK TSH 3RD-GEN ASSAYJLW1997-08-29
109881351695548K972265A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZERLCP1997-09-25
109881326343303K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMKHO1997-06-27
963631326343303K971103AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEMKHO1997-06-27
109881888340823K964348AIA-PACK B12 ASSAYCDD1997-01-13
109861888340823K964348AIA-PACK B12 ASSAYCDD1997-01-13
109881885985954K954591AIA-PACK CORT ASSAYJFT1995-12-15
109861885985954K954591AIA-PACK CORT ASSAYJFT1995-12-15
109881395768694K936229AIA-PACK TT3 ASSAYCDP1994-07-14
109861395768694K936229AIA-PACK TT3 ASSAYCDP1994-07-14
109861759665613K932178AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TESJJX1993-09-21
109881759665613K932178AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TESJJX1993-09-21
109861325823997K924863AIA-PACK FSH CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109881325823997K924863AIA-PACK FSH CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109861615865659K924860AIA-PACK AFP CALIBRATION VERIFICATION TEST SETJJX1993-03-04
109881615865659K924860AIA-PACK AFP CALIBRATION VERIFICATION TEST SETJJX1993-03-04
109861383643045K924858AIA-PACK FER CALIBRATION VERIFICATION TEST SETDBF1992-12-15
109881383643045K924858AIA-PACK FER CALIBRATION VERIFICATION TEST SETDBF1992-12-15
109881043642936K924857AIA-PACK CEA CALIBRATION VERIFICATION TEST SETDHX1993-03-18
109861043642936K924857AIA-PACK CEA CALIBRATION VERIFICATION TEST SETDHX1993-03-18
109881648812849K924856AIA-PACK PRL CALIBRATION VERIFICATION TEST SETJJX1993-01-11
109861648812849K924856AIA-PACK PRL CALIBRATION VERIFICATION TEST SETJJX1993-01-11
109861020275674K924854AIA-PACK PAP CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109881020275674K924854AIA-PACK PAP CALIBRATION VERIFICATION TEST SETJJX1992-11-16
109861867246734K924853AIA-PACK BHCG CALIBRATION VERIFICATION TEST SETJJX1992-12-28
109881867246734K924853AIA-PACK BHCG CALIBRATION VERIFICATION TEST SETJJX1992-12-28
109881285329487K913663AIA-PACK T-UKHQ1991-09-30
109861285329487K913663AIA-PACK T-UKHQ1991-09-30
109881329801099K913493AIA-PACK FT4CEC1991-09-10
109861329801099K913493AIA-PACK FT4CEC1991-09-10
109881280382570K913298AIA-PACK CK-MBJHX1991-09-27
109861280382570K913298AIA-PACK CK-MBJHX1991-09-27
109881472316268K900440AIA-PACK BMGJZG1990-02-26
109861472316268K900440AIA-PACK BMGJZG1990-02-26
109861366343322K896982AIA-PACK T4KLI1990-03-09
109881366343322K896982AIA-PACK T4KLI1990-03-09
109861330558953K870521TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAYJHI1987-04-08
109881330558953K870521TANDEM(R) M-PAK(TM) TOTAL B-HCG IMMUNOENZY. ASSAYJHI1987-04-08
109881036936848K864945TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAYJFH1987-01-05
109861036936848K864945TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAYJFH1987-01-05
109861632189541K863861TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONAJHI1986-11-21
109881632189541K863861TANDEM-M IMMUNOENZYMETRIC ASSAY FOR HUM/CHOR/GONAJHI1986-11-21
109861146493782K863345TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAYDBF1986-10-08
109881146493782K863345TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAYDBF1986-10-08
109861045737055K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMJZT1986-08-15
109881045737055K862674PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEMJZT1986-08-15
109881513799368K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ2025-10-03
963631513799368K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01PDJ2025-10-03
109861917542134K192380ST AIA-PACK BNPNBC2020-08-24
109881917542134K192380ST AIA-PACK BNPNBC2020-08-24
109861650154738K160113ST AIA-PACK hsE2 Calibrator SetJIT2016-02-17
109881650154738K160113ST AIA-PACK hsE2 Calibrator SetJIT2016-02-17
109881364246182K153417ST AIA-PACK PROG III Calibrator SetJIT2015-12-18
109861364246182K153417ST AIA-PACK PROG III Calibrator SetJIT2015-12-18
109881696956661K150270ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment SetMRG2015-10-26
109861696956661K150270ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment SetMRG2015-10-26
109861996398078K143296AIA-PACK C-Peptide Control SetJJX2014-12-16
109881996398078K143296AIA-PACK C-Peptide Control SetJJX2014-12-16
109881577994464K143144ST AIA-PACK PROG II Calibrator SetJIT2014-12-03
109861577994464K143144ST AIA-PACK PROG II Calibrator SetJIT2014-12-03
109881126446878K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ2015-07-02
109861126446878K143075ST AIA-PACK SHBG, ST AIA-PACK SHBG Calibrator SetCDZ2015-07-02
109881491418526K140648ST AIA-PACK C-PEPTIDE II CALIBRATOR SETJIT2014-04-10
109861491418526K140648ST AIA-PACK C-PEPTIDE II CALIBRATOR SETJIT2014-04-10
109861977933050K123131ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AIMRG2013-02-08
109881977933050K123131ST AIA-PACK 25-OH VITAMIN D, ST AIA-PACK 25-OH VITAMIN D CALIBRATOR SET, AIA-PACK 25-OH VITAMIN D CONTROL SET, AND ST AIMRG2013-02-08
109881025582729K121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETLPS2012-06-15
109861025582729K121533ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETLPS2012-06-15
109881491114541K111762ST AIA-PACK DHEA-S CALIBRATOR SETJIT2011-08-05
109861491114541K111762ST AIA-PACK DHEA-S CALIBRATOR SETJIT2011-08-05
109861342967439K111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321CKG2011-12-01
109881342967439K111335ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321CKG2011-12-01
109882010326540K100304ST AIA PACK HBA1CLCP2010-08-27
109862010326540K100304ST AIA PACK HBA1CLCP2010-08-27
109861682667738K093960ST AIA-PACK CYSTATIN C, MODEL 025217NDY2010-09-14
109881682667738K093960ST AIA-PACK CYSTATIN C, MODEL 025217NDY2010-09-14
109862020179666K091332AIA-PACK RBC FOLATECGN2009-10-02
109882020179666K091332AIA-PACK RBC FOLATECGN2009-10-02
963631240554016K071132G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8LCP2008-09-16
109881240554016K071132G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8LCP2008-09-16
109881297596906K063605ST AIA-PACK INTACT PTH ASSAYCEW2007-06-21
109861297596906K063605ST AIA-PACK INTACT PTH ASSAYCEW2007-06-21
109861199035637K023894ST AIA-PACK AFP ENZYME IMMUNOASSAYLOJ2002-12-17
109881199035637K023894ST AIA-PACK AFP ENZYME IMMUNOASSAYLOJ2002-12-17
109881219427465K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYDHX2002-12-18
109861219427465K023893ST AIA-PACK CEA ENZYME IMMUNOASSAYDHX2002-12-18
109861406847799K023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYLTK2002-12-06
109881406847799K023891ST AIA-PACK CA 125 ENZYME IMMUNOASSAYLTK2002-12-06
109881198548859K023240ST AIA-PACK CA 19-9NIG2002-12-23
109861198548859K023240ST AIA-PACK CA 19-9NIG2002-12-23
109881293293808K023091ST AIA-PACK TESTOSTERONE ASSAYCDZ2002-12-17
109861293293808K023091ST AIA-PACK TESTOSTERONE ASSAYCDZ2002-12-17
963631184354593K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEJPD2002-05-14
109881184354593K020489G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODEJPD2002-05-14
109861721375164K012820AIA-PACK CTNI 2ND-GEN ASSAYMMI2001-12-14
109881721375164K012820AIA-PACK CTNI 2ND-GEN ASSAYMMI2001-12-14
109881159851841K011434G7 AUTOMATED HPLC ANALYZERLCP2001-09-18
963631159851841K011434G7 AUTOMATED HPLC ANALYZERLCP2001-09-18
109861944554923K010796AIA-PACK BRCA, ST AIA PACK BRCAMOI2001-08-16
109881944554923K010796AIA-PACK BRCA, ST AIA PACK BRCAMOI2001-08-16
963631003209124
109881003209124
109881042790271

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JJX142014-12-16
JIT102016-02-17
LCP72010-08-27
NBC42020-08-24
MRG42015-10-26
CDZ42015-07-02
CGN42009-10-02
DHX42002-12-18
CDP41999-05-11
JZO41998-10-08
DBF41992-12-15
JHI41987-04-08
PDJ22025-10-03
LPS22012-06-15
CKG22011-12-01
NDY22010-09-14
CEW22007-06-21
NIG22002-12-23
LOJ22002-12-17
LTK22002-12-06
JPD22002-05-14
MMI22001-12-14
MOI22001-08-16
DDR21998-05-28
DGC21997-10-03
JLW21997-08-29
KHO21997-06-27
CDD21997-01-13
JFT21995-12-15
MTF21993-07-07
KHQ21991-09-30
JHX21991-09-27
CEC21991-09-10
KLI21990-03-09
JZG21990-02-26
JFH21987-01-05
JZT21986-08-15