CORTISOL CLASP-BEAD EIA KIT— 510(k) K895407

Name: FDA 510(k) clearance K895407
Creator: U.S. Food and Drug Administration
Published: 1989-10-19

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K895407 for CORTISOL CLASP-BEAD EIA KIT, Substantially Equivalent on 1989-10-19. Applicant: Biotecx Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code CGR
Device class: Class 2
Regulation: 21 CFR 862.1205
Advisory panel: Clinical Chemistry
Date received: 1989-09-06
Decision date: 1989-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friendswood, TX, US

Download summary PDF View on FDA.gov ↗

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