STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)— 510(k) K965168

Name: FDA 510(k) clearance K965168
Creator: U.S. Food and Drug Administration
Published: 1997-02-04

Substantially Equivalent

Specialized Assays, Inc.

FDA 510(k) clearance K965168 for STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002), Substantially Equivalent on 1997-02-04. Applicant: Specialized Assays, Inc.. Device class: 1.

Clearance details

Applicant: Specialized Assays, Inc.
Product code: Code JJT
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1996-12-24
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pipersville, PA, US

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K965169 — STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)1997-02-06
K965166 — STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)1997-02-04

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