LDH ISOENZYME CONTROL— 510(k) K771894

Name: FDA 510(k) clearance K771894
Creator: U.S. Food and Drug Administration
Published: 1977-12-22

Substantially Equivalent

Bio-Reagents & Diagnostics, Inc.

FDA 510(k) clearance K771894 for LDH ISOENZYME CONTROL, Substantially Equivalent on 1977-12-22. Applicant: Bio-Reagents & Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Reagents & Diagnostics, Inc.
Product code: Code CEX
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1977-10-06
Decision date: 1977-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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