RNA MEDICAL HEMAT CONTROL— 510(k) K955630

Substantially Equivalent

Bionostics, Inc.

FDA 510(k) clearance K955630 for RNA MEDICAL HEMAT CONTROL, Substantially Equivalent on 1996-03-01. Applicant: Bionostics, Inc.. Device class: 1.

Clearance details

Applicant: Bionostics, Inc.
Product code: Code JJR
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1995-12-11
Decision date: 1996-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Acton, MA, US

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