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Infrared Laboratory Systems dba SYNERMED

Matched from indexed company URL: INFRARED LABORATORY SYSTEMS LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035939733003593973Infrared Laboratory Systems dba SYNERMED1N2026-01-0117408 Tiller Ct Ste 1900 WESTFIELD IN US 46074

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05060500090029Synermed® - Albumin Reagent 6 X 250 mL317 896-1565info@irlabsystems.com
05060500090036Synermed® - Albumin Reagent 2 X 250 mL317 896-1565info@irlabsystems.com
05060500090043Synermed® - Albumin Reagent 4 X 55 mL317 896-1565info@irlabsystems.com
05060500090050Synermed® - Albumin Reagent 8 X 50 mL317 896-1565info@irlabsystems.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1347622072939915K974909
1347621363488676K973109SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KITCIG1997-09-25
1347621792323409K972716SYNERMED TOTAL BILIRUBIN REAGENT KITCIG1997-08-07
1347622044045732K971491SYNERMED IR 200 CHEMISTRY ANALYZERJJF1997-06-26
1347621340322301K962479SYNERMED ISE REAGENTSCGZ1997-03-03
1347621360347332K960793SYNERMED ENZYMATIC CO2 REAGENT KITKHS1996-03-11
1347621486127230K953395SYNERMED CALCIUM REAGENT KITCJY1995-08-31
1347621016305961K952179SYNERMED ISE REAGENTSJGS1995-06-20
1347621734974909K943924CREATININE-PO REAGENT KITCGX1994-09-20
1347621766163890K941091SYNERMED AMYLASE REAGENT KITJFJ1994-05-03
1347621071314315K940571SYNERMEDIR CAL I AND SYNERMED IR CAL IIJIX1994-04-21
1347621873838668K935662SYNERMED IR 500 CHEMISTRY ANALYZERJIQ1994-04-26
1347621229147684K931986AMP ALKALINE PHOSPHATASE REAGENT KITCJE1993-09-08
1347621267651638K931958SYNERMED GGT REAGENT KITJQB1993-09-08
1347621859473211K930932SYNERMED CREATINE KINASE REAGENT KITCGS1993-05-11
1347621002125177K926511SYNERMED SINGLE REAGENT CREATININE KITCGX1993-02-18
1347621126464899K924428SYNERMED ENZYMATIC CO2 REAGENT KITKHS1992-12-03
1347622004116982K924427SYNERMED HDL CHOLESTLEROL REAGENT KITLBR1992-11-09
1347621051048874K923414SYNERMED 600 NM URIC ACID REAGENT KITKNK1992-09-22
1347621038670681K922784SYNERMED UIBC REAGENT KITJMO1992-07-21
1347621252745907K921025SYNERMED LDHH-L REAGENT KITCFJ1992-03-23
1347621727525186K921016SYNERMED ALT/GPT REAGENT KITCKA1992-05-07
1347621688791331K915555SYNERMED AST/GOT REAGENT KITCIT1992-01-27
1347621812572949K912912SYNERMED SERUM IRON-600 REAGENT KITCFM1991-07-30
1347621691875979K912569SYNERMED PHOSPHORUS REAGENT KITCEO1991-07-17
1347621446538413K911248SYNERMED UREA NITROGEN REAGENT KITCDQ1991-06-03
1347621076395137K903543SYNERMED ALBUMIN REAGENT KITCIX1990-10-12
1347621060970153K903511SYNERMED TOTAL PROTEIN REAGENT KITCEK1990-09-07
1347621082242596K903296SYNERMED CREATININE REAGENT KITCGX1990-08-17
1347621374914391K903233SYNERMED CALCIUM REAGENT KITCIC1990-10-04
1347621338156526K903103SYNERMED CHLORIDE REAGENT KITCHG1990-08-09
1347621155129690K903063SYNERMED GLUCOSE REAGENT KITCGA1990-09-13
1347621997474635K903016SYNERMED TRIGLYCERIDES REAGENT KITCDT1990-07-27
1347621502137587K903015SYNERMED CHOLESTEROL REAGENT KITCHH1990-10-01
1347621432566099K902919SYNERMED MAGNESIUM REAGENT KITJGJ1990-07-31
1347621826671190K902918SYNERMED SERUM IRON REAGENT KITCFM1990-07-31
1347621791032037K153692Synermed Glucose Reagent, Synermed IR-1200 Chemistry AnalyzerCGA2016-06-24
1347621138862073K133710LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLSDKB2014-02-21
1347621692474758K091455DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CALMZV2009-08-14
1347621675572674K082763DIAZYME LIQUID STABLE ENZYMATIC SODIUM ASSAY, MODEL DZ114BMZU2008-11-12
1347621677896039K072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSLBR2008-01-22
1347621756552624K072395DIAZYME HDL-CHOLESTEROL REAGENT,CALIBRATOR, CONTROLSLBS2008-01-03
1347621207101781
1347621652482891

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CGX31994-09-20
CGA22016-06-24
LBR22008-01-22
CIG21997-09-25
KHS21996-03-11
CFM21991-07-30
DKB12014-02-21
MZV12009-08-14
MZU12008-11-12
LBS12008-01-03
JJF11997-06-26
CGZ11997-03-03
CJY11995-08-31
JGS11995-06-20
JFJ11994-05-03
JIQ11994-04-26
JIX11994-04-21
JQB11993-09-08
CJE11993-09-08
CGS11993-05-11
KNK11992-09-22
JMO11992-07-21
CKA11992-05-07
CFJ11992-03-23
CIT11992-01-27
CEO11991-07-17
CDQ11991-06-03
CIX11990-10-12
CIC11990-10-04
CHH11990-10-01
CEK11990-09-07
CHG11990-08-09
JGJ11990-07-31
CDT11990-07-27

PMN#

GUDID#

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