STRATUS CARBAMAZEPINE FLUROMETRIC— 510(k) K832447

Name: FDA 510(k) clearance K832447
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

American Dade

FDA 510(k) clearance K832447 for STRATUS CARBAMAZEPINE FLUROMETRIC, Substantially Equivalent on 1983-09-12. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1983-07-25
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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