ELECSYS CALCHECK FOLATE— 510(k) K974384

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K974384 for ELECSYS CALCHECK FOLATE, Substantially Equivalent on 1997-12-08. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 1997-11-21
Decision date: 1997-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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