OPTICOAT T4 EIA KIT— 510(k) K982298

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K982298 for OPTICOAT T4 EIA KIT, Substantially Equivalent on 1999-02-03. Applicant: Biotecx Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1998-07-01
Decision date: 1999-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Biotecx Laboratories, Inc.

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K892853 — T4 CLASP-BEAD EIA KIT1989-05-22
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