RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600— 510(k) K891990

Name: FDA 510(k) clearance K891990
Creator: U.S. Food and Drug Administration
Published: 1989-06-15

Substantially Equivalent

Clinical Sciences, Inc.

FDA 510(k) clearance K891990 for RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600, Substantially Equivalent on 1989-06-15. Applicant: Clinical Sciences, Inc.. Device class: 1.

Clearance details

Applicant: Clinical Sciences, Inc.
Product code: Code LJB
Device class: Class 1
Regulation: 21 CFR 866.3520
Advisory panel: Microbiology
Date received: 1989-03-28
Decision date: 1989-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Whippany, NJ, US

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