510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950803Substantially Equivalent

Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample

Isolab, Inc., Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950803 is the FDA 510(k) clearance record for ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE, a class I device, cleared for Isolab, Inc. on under FDA product code JJT (Enzyme Controls (Assayed And Unassayed)). FDA records list 44 510(k) clearances for Isolab, Inc., from to . As of , FDA records show 2 recalls naming K950803.

Clearance record

Decision date
Received
(212 days to decision)
Product code
JJT Enzyme Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Isolab, Inc. Drawer 4350, Akron OH
510(k) summary
Summary
Third party review
No

Clearances, product code JJT

Trailing 12 months

FDA records hold no clearances under product code JJT in the trailing twelve months.

FDA records show no clearances under product code JJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260