STACLOT(R) PROTEIN S TEST KIT— 510(k) K913424

Name: FDA 510(k) clearance K913424
Creator: U.S. Food and Drug Administration
Published: 1991-10-08

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K913424 for STACLOT(R) PROTEIN S TEST KIT, Substantially Equivalent on 1991-10-08. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1991-08-01
Decision date: 1991-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K913424

K-number listed on FDA's recall record

Z-3047-2026 — STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency testClass II·Ongoing·Diagnostica Stago, Inc.·20260729

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K913424.

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