ENZYMUN TEST TBG— 510(k) K862109

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K862109 for ENZYMUN TEST TBG, Substantially Equivalent on 1986-06-30. Applicant: Boehringer Mannheim Corp.. Device class: 2.

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code CEE
Device class: Class 2
Regulation: 21 CFR 862.1685
Advisory panel: Clinical Chemistry
Date received: 1986-06-03
Decision date: 1986-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEE

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K905777 — MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT1991-01-30
K900240 — DELFIA TBG KIT1990-03-30

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Data sourced from openFDA. This site is unofficial and independent of the FDA.