OLYMPUS ACID PHOSPHATASE REAGENT— 510(k) K963640

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K963640 for OLYMPUS ACID PHOSPHATASE REAGENT, Substantially Equivalent on 1997-02-18. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant
Olympus America, Inc.
Product code
Code CKB
Device class
Class 2
Regulation
21 CFR 862.1020
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Melville, NY, US
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