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510(k) K991371

CARESIDE AMMONIA by Careside, Inc. — Product Code JID

K991371 is an FDA 510(k) premarket notification submitted by Careside, Inc. for the device "CARESIDE AMMONIA". The FDA issued a decision of Substantially Equivalent on August 3, 1999. The device falls under product code JID (Photometric Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Careside, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1999
Date Received
April 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Ammonia
Device Class
Class I
Regulation Number
862.1065
Review Panel
CH
Submission Type

Other clearances by Careside, Inc.

  • K020484 — CARESIDE LDH (July 3, 2002)
  • K020486 — CARESIDE GGT (July 1, 2002)
  • K020487 — CARESIDE ALT (June 4, 2002)
  • K020488 — CARESIDE TRGLYCERIDE (April 15, 2002)
  • K002792 — CARESIDE CHOLINESTERASE (November 8, 2000)
  • K001462 — CARESIDE HEMOGLOBIN (August 21, 2000)
  • K993771 — CARESIDE DIRECT BILIRUBIN (December 27, 1999)
  • K993634 — CARESIDE ANALYZER (December 2, 1999)
  • K992475 — CARESIDE CO2, TOTAL (September 15, 1999)
  • K991717 — CARESIDE MG (August 10, 1999)

Other clearances for product code JID

  • K820723 — KODAK EKTACHEM CLINICAL CHEM. NH3 (April 1, 1982)
  • K813366 — AMMONIA TEST (December 22, 1981)

FDA data resources