CK— 510(k) K983070

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983070 for CK, Substantially Equivalent on 1999-02-16. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1998-09-02
Decision date: 1999-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K983070

K-number listed on FDA's recall record

Z-1075-2019 — Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.Class II·Terminated·Abbott Laboratories, Inc·20180718
Z-1076-2019 — Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.Class II·Terminated·Abbott Laboratories, Inc·20180718

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983070.

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