CONTROLCHEK(TM)— 510(k) K871445

Name: FDA 510(k) clearance K871445
Creator: U.S. Food and Drug Administration
Published: 1987-04-29

Substantially Equivalent

Petra Biomedical Products, Inc.

FDA 510(k) clearance K871445 for CONTROLCHEK(TM), Substantially Equivalent on 1987-04-29. Applicant: Petra Biomedical Products, Inc.. Device class: 1.

Clearance details

Applicant: Petra Biomedical Products, Inc.
Product code: Code JTO
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1987-04-13
Decision date: 1987-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

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