510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K970664Substantially Equivalent

Glucose Reagent

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

K970664 is the FDA 510(k) clearance record for GLUCOSE REAGENT, a class II device, cleared for Derma Media Lab., Inc. on under FDA product code CFR (Hexokinase, Glucose). FDA records list 18 510(k) clearances for Derma Media Lab., Inc., from to . As of , FDA records show no recalls naming K970664.

Clearance record

Decision date
Received
(161 days to decision)
Product code
CFR Hexokinase, Glucose
Regulation
21 CFR 862.1345
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 CFR

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