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510(k) K915707

AMMONIA REAGENT SET by Tech Intl. Co. — Product Code JIF

K915707 is an FDA 510(k) premarket notification submitted by Tech Intl. Co. for the device "AMMONIA REAGENT SET". The FDA issued a decision of Substantially Equivalent on February 26, 1992. The device falls under product code JIF (Enzymatic Method, Ammonia), a Class I device regulated under 21 CFR 862.1065. Tech Intl. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1992
Date Received
November 29, 1991
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 Tech Intl. Co.

  • K915704 — AMYLASE (KINETIC) REAGENT SET (June 28, 1996)
  • K915705 — ACID PHOSPHATASE REAGENT SET (February 27, 1992)
  • K914158 — URIC ACID REAGENT SET (February 21, 1992)
  • K915706 — LIPASE REAGENT SET (February 18, 1992)
  • K915710 — AMYLASE (COLORIMETRIC) REAGENT SET (January 30, 1992)
  • K914160 — CHOLESTEROL REGEANT SET (January 30, 1992)
  • K915709 — CREATINE KINASE-MB (CK-MB) REAGENT SET (January 27, 1992)
  • K914159 — GLUCOSE REAGENT SET (January 27, 1992)
  • K915708 — INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET (January 22, 1992)
  • K914171 — IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE (December 18, 1991)

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