ELECSYS AFP— 510(k) K973351

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K973351 for ELECSYS AFP, Substantially Equivalent on 1997-11-21. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code LOJ
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1997-09-05
Decision date: 1997-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

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K984372 — ELECSYS CALCHECK TROPONIN T1998-12-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.