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

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..

Clearance details

Applicant: Emd Chemicals, Inc.
Product code: Code CIJ
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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