BIO-SCIENCE LABORATORIES T4 REAGENT— 510(k) K834023

Name: FDA 510(k) clearance K834023
Creator: U.S. Food and Drug Administration
Published: 1984-01-24

Substantially Equivalent

Biosan Laboratories, Inc.

FDA 510(k) clearance K834023 for BIO-SCIENCE LABORATORIES T4 REAGENT, Substantially Equivalent on 1984-01-24. Applicant: Biosan Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biosan Laboratories, Inc.
Product code: Code CDX
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1983-11-22
Decision date: 1984-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K932980 — TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-1161993-10-18

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