510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991371Substantially Equivalent

Careside Ammonia

Careside, Inc., Culver City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991371 is the FDA 510(k) clearance record for CARESIDE AMMONIA, a class I device, cleared for Careside, Inc. on under FDA product code JID (Photometric Method, Ammonia). FDA records list 22 510(k) clearances for Careside, Inc., from to . As of , FDA records show no recalls naming K991371.

Clearance record

Decision date
Received
(105 days to decision)
Product code
JID Photometric Method, Ammonia
Regulation
21 CFR 862.1065
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Careside, Inc. 6100 Bristol Pkwy., Culver City CA
510(k) summary
Summary
Third party review
No

Clearances, product code JID

Trailing 12 months
1 clearance under product code JID in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JID, 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 20261
October 20260