HDLC PRECIPITATING REAGENT— 510(k) K982539

Name: FDA 510(k) clearance K982539
Creator: U.S. Food and Drug Administration
Published: 1998-09-15

Substantially Equivalent

Ac Biochemicals, Inc.

FDA 510(k) clearance K982539 for HDLC PRECIPITATING REAGENT, Substantially Equivalent on 1998-09-15. Applicant: Ac Biochemicals, Inc.. Device class: 1.

Clearance details

Applicant: Ac Biochemicals, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1998-07-21
Decision date: 1998-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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