HICHEM Y-GT REAGENT KIT— 510(k) K946192

Substantially Equivalent

Hichem Diagnostics

FDA 510(k) clearance K946192 for HICHEM Y-GT REAGENT KIT, Substantially Equivalent on 1995-05-02. Applicant: Hichem Diagnostics. Device class: 1.

Clearance details

Applicant: Hichem Diagnostics
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1994-12-20
Decision date: 1995-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES1997-01-13
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K963383 — HICHEM ALP/AMP REAGENT KIT1996-09-23
K953860 — HICHEM ISE DILUENT KIT 700081995-09-06
K953861 — HICHEM ISE INTDERNAL REFERENCE KIT 700091995-09-06
K953862 — HICHEM ISEKCI SOLUTION KIT 700101995-09-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.