STACLOT LA TEST KIT— 510(k) K923731

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K923731 for STACLOT LA TEST KIT, Substantially Equivalent on 1992-12-23. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GFO
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1992-07-27
Decision date: 1992-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K923731

K-number listed on FDA's recall record

Z-0610-2019 — Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).Class II·Terminated·Diagnostica Stago, Inc.·20181114
Z-0611-2019 — Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).Class II·Terminated·Diagnostica Stago, Inc.·20181114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K923731.

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