CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY— 510(k) K873282

Name: FDA 510(k) clearance K873282
Creator: U.S. Food and Drug Administration
Published: 1987-09-22

Substantially Equivalent

Windsor Laboratories, Inc.

FDA 510(k) clearance K873282 for CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY, Substantially Equivalent on 1987-09-22. Applicant: Windsor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Windsor Laboratories, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1987-08-17
Decision date: 1987-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garland, TX, US

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