IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530— 510(k) K872942

Substantially Equivalent

Clinical Sciences, Inc.

FDA 510(k) clearance K872942 for IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530, Substantially Equivalent on 1988-01-11. Applicant: Clinical Sciences, Inc.. Device class: 2.

Clearance details

Applicant
Clinical Sciences, Inc.
Product code
Code LKQ
Device class
Class 2
Regulation
21 CFR 866.3175
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Whippany, NJ, US
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