AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)— 510(k) K951494

Name: FDA 510(k) clearance K951494
Creator: U.S. Food and Drug Administration
Published: 1995-12-11

Substantially Equivalent

Emd Chemicals, Inc.

FDA 510(k) clearance K951494 for AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR), Substantially Equivalent on 1995-12-11. Applicant: Emd Chemicals, Inc.. Device class: 2.

Clearance details

Applicant: Emd Chemicals, Inc.
Product code: Code CIJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1995-03-31
Decision date: 1995-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

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