510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971309Substantially Equivalent

Urea

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

K971309 is the FDA 510(k) clearance record for UREA, a class II device, cleared for Derma Media Lab., Inc. on under FDA product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen). FDA records list 18 510(k) clearances for Derma Media Lab., Inc., from to . As of , FDA records show no recalls naming K971309.

Clearance record

Decision date
Received
(115 days to decision)
Product code
CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Regulation
21 CFR 862.1770
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 CDQ

Trailing 12 months

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

FDA records show no clearances under product code CDQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CDQ, 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