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510(k) K032862

Device
INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM
Applicant
INTERLAB S.R.L.
510(k) number
K032862
Product code
JBD  
Decision
Substantially Equivalent (SESE)
Decision date
2004-02-03
Date received
2003-09-12
Regulation
864.7440
Classification name
System, Analysis, Electrophoretic Hemoglobin
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gary Lehnus
Address
150 Cherry Ln. Rd. East Stroudsburg PA US 18301 18301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JBD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K053571MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMInterlab S.R.L.2006-06-30
K992199ACID HEMOGLOBIN KITHelena Laboratories1999-09-21
K991362HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)Morax1999-06-21
K982426SPIFE ALKALINE HEMOGLOBINHelena Laboratories1998-12-17
K931503REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena Laboratories1993-08-16
K931465REP ALKALINE HB-15 #3196,-8 #3197,-4 3198Helena Laboratories1993-07-06
K901143REP HEMOGLOBIN IEF KITS (CAT. NO. 3250)Helena Laboratories1990-05-23
K830804LABILE REMOVING HEMOLYZING REAGENTCorning Medical & Scientific1983-05-04
K820518GELMAN GLYCO-PHORE BUFFERGelman Sciences, Inc.1982-04-09
K813395CELLULOSE ACETATE-CITRATE AGAR HEMOGLOHelena Laboratories1981-12-31
K810919HEMOGLOBIN ELECTROPHORESIS CONTROLIsolab, Inc.1981-04-23
K810047AUTOPHOR 128Gelman Sciences, Inc.1981-02-05
K802884CORNING NORMAL GLYCOSYLATED HEMOGLOBINCorning Medical & Scientific1980-12-22
K802821PARAGON HEMOGLOBIN ELECTRO. REAG. KITBeckman Instruments, Inc.1980-12-11
K800853A,SA2 LYOPHILIZED HEMO CONTROLHelena Laboratories1980-04-29

Legacy Summary#

summary

FDA Review#

Decision Summary