ABBOTT ARCHITECT TESTOSTERONE— 510(k) K983212

Name: FDA 510(k) clearance K983212
Creator: U.S. Food and Drug Administration
Published: 1998-11-18

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983212 for ABBOTT ARCHITECT TESTOSTERONE, Substantially Equivalent on 1998-11-18. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CDZ
Device class: Class 1
Regulation: 21 CFR 862.1680
Advisory panel: Clinical Chemistry
Date received: 1998-09-14
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K983212

K-number listed on FDA's recall record

Z-0271-2022 — ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89Class II·Ongoing·Abbott Laboratories·20210929
Z-0272-2022 — ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;Class II·Ongoing·Abbott Laboratories·20210929

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983212.

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