HICHEM CK/NAC REAGENT KIT— 510(k) K962247

Substantially Equivalent

Elan Pharma, Inc.

FDA 510(k) clearance K962247 for HICHEM CK/NAC REAGENT KIT, Substantially Equivalent on 1996-08-15. Applicant: Elan Pharma, Inc.. Device class: 2.

Clearance details

Applicant: Elan Pharma, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1996-06-11
Decision date: 1996-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Elan Pharma, Inc.

K982469 — HICHEM CHOLESTEROL REAGENT KIT1998-08-19
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K960115 — HICHEM BUN/UREA REAGENT KIT1996-03-29

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