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510(k) K932556

AMMONIA ASSAY CAT. NO. 200-02 by Diagnostic Chemicals, Ltd. (Usa) — Product Code JIF

K932556 is an FDA 510(k) premarket notification submitted by Diagnostic Chemicals, Ltd. (Usa) for the device "AMMONIA ASSAY CAT. NO. 200-02". The FDA issued a decision of Substantially Equivalent on August 2, 1994. The device falls under product code JIF (Enzymatic Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Diagnostic Chemicals, Ltd. (Usa) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1994
Date Received
May 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Diagnostic Chemicals, Ltd. (Usa)

  • K022538 — IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 (August 23, 2002)
  • K974874 — BILIRUBIN-SL (TOTAL) ASSAY (February 12, 1998)
  • K932766 — HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM) (December 10, 1993)
  • K932555 — DC-LINEATE CAT. NO. SE-091 (August 19, 1993)
  • K925877 — DC-UIBC-CAL (March 18, 1993)
  • K912825 — MAGNESIUM ASSAY KIT, CAT.# 100-12 (July 26, 1991)
  • K895964 — DCL SYPHILIS-M CATALOG NO. 600-80 (January 8, 1991)
  • K895965 — DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (December 26, 1990)
  • K904660 — ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 (November 20, 1990)
  • K901510 — ENZYMATIC THEOPHYLLINE REAGENT, #500-82 (June 12, 1990)

Other clearances for product code JIF

  • K183517 — Ammonia II (February 8, 2019)
  • K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (C (March 7, 2013)
  • K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE (February 15, 2013)
  • K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE (September 6, 2006)
  • K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (November 25, 2005)
  • K033921 — AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10 (March 10, 2004)
  • K030873 — RANDOX AMMONIA (May 12, 2003)
  • K023841 — AMMONIA ASSAY FOR THE ADVIA 1650 (December 24, 2002)
  • K021151 — AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (July 13, 2002)
  • K003196 — SYNCHRON SYSTEMS AMMONIA REAGENT (December 22, 2000)

FDA data resources