T3 CLASP-BEAD EIA KIT— 510(k) K893620

Name: FDA 510(k) clearance K893620
Creator: U.S. Food and Drug Administration
Published: 1989-08-11

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K893620 for T3 CLASP-BEAD EIA KIT, Substantially Equivalent on 1989-08-11. Applicant: Biotecx Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1989-05-11
Decision date: 1989-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Friendswood, TX, US

Download summary PDF View on FDA.gov ↗

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K892853 — T4 CLASP-BEAD EIA KIT1989-05-22
K883765 — TBG 125I RIA KIT, RADIOIMMUNO. OF SERUM THYROXINE1988-10-31
K871211 — PROGESTERONE CLASP RADIOIMMUNOASSAY KIT1987-04-13

Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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