510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955938Substantially Equivalent

Creatinine Reagent

Derma Media Lab., Inc., Santa Fe Springs CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955938 is the FDA 510(k) clearance record for CREATININE REAGENT, a class II device, cleared for Derma Media Lab., Inc. on under FDA product code CGX (Alkaline Picrate, Colorimetry, Creatinine). FDA records list 18 510(k) clearances for Derma Media Lab., Inc., from to . As of , FDA records show no recalls naming K955938.

Clearance record

Decision date
Received
(82 days to decision)
Product code
CGX Alkaline Picrate, Colorimetry, Creatinine
Regulation
21 CFR 862.1225
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Derma Media Lab., Inc. 8531 Wellsford Pl., Suite E, Santa Fe Springs CA
510(k) summary
Statement
Third party review
No

Clearances, product code CGX

Trailing 12 months
2 clearances under product code CGX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CGX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260