OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT— 510(k) K953437

Name: FDA 510(k) clearance K953437
Creator: U.S. Food and Drug Administration
Published: 1995-10-20

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K953437 for OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT, Substantially Equivalent on 1995-10-20. Applicant: Olympus America, Inc.. Device class: 1.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code GTQ
Device class: Class 1
Regulation: 21 CFR 866.3720
Advisory panel: Microbiology
Date received: 1995-07-21
Decision date: 1995-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

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