SEROTONIN ENZYME IMMUNOASSAY— 510(k) K903609

Substantially Equivalent

Immunotech Corp.

FDA 510(k) clearance K903609 for SEROTONIN ENZYME IMMUNOASSAY, Substantially Equivalent on 1990-10-22. Applicant: Immunotech Corp.. Device class: 1.

Clearance details

Applicant: Immunotech Corp.
Product code: Code CDA
Device class: Class 1
Regulation: 21 CFR 862.1390
Advisory panel: Clinical Chemistry
Date received: 1990-08-09
Decision date: 1990-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cedex 9 (France), FR

Download summary PDF View on FDA.gov ↗

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K931228 — PROGESTERONE RADIOIMMUNOASSAY KIT1993-10-22
K911634 — MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST1991-06-24

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