ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS— 510(k) K791373

Name: FDA 510(k) clearance K791373
Creator: U.S. Food and Drug Administration
Published: 1979-10-26

Substantially Equivalent

Hoffmann-La Roche, Inc.

FDA 510(k) clearance K791373 for ROCHE IMMUNOCHEMICAL LD ISOENZY REAGENTS, Substantially Equivalent on 1979-10-26. Applicant: Hoffmann-La Roche, Inc.. Device class: 2.

Clearance details

Applicant: Hoffmann-La Roche, Inc.
Product code: Code CFE
Device class: Class 2
Regulation: 21 CFR 862.1445
Advisory panel: Clinical Chemistry
Date received: 1979-07-24
Decision date: 1979-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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