ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE

Enzyme Controls (assayed And Unassayed)

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Isolab's Galactose-1-phosphate Uridyl Tranferase Test Kits 800, 4000 Sample.

Pre-market Notification Details

Device IDK950803
510k NumberK950803
Device Name:ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactJanet Perkins
CorrespondentJanet Perkins
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-21
Decision Date1995-09-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147001279 K950803 000
06438147001262 K950803 000

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