PROCHECK(TM) BLIND PERFORMANCE SPECIMENS— 510(k) K931105

Substantially Equivalent

Dynagen, Inc.

FDA 510(k) clearance K931105 for PROCHECK(TM) BLIND PERFORMANCE SPECIMENS, Substantially Equivalent on 1993-04-21. Applicant: Dynagen, Inc.. Device class: 1.

Clearance details

Applicant
Dynagen, Inc.
Product code
Code DIF
Device class
Class 1
Regulation
21 CFR 862.3280
Advisory panel
Clinical Toxicology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Cambridge, MA, US
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