UNICALIBRATOR KIT— 510(k) K922021

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K922021 for UNICALIBRATOR KIT, Substantially Equivalent on 1992-06-09. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code GIZ
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1992-04-30
Decision date: 1992-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GIZ

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K042941 — DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS2004-12-02
K023309 — CONTROL PLASMA N2002-11-01
K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-102001-12-10
K003328 — ACCUCLOT CONTROL I, MODEL A40892001-03-01

More clearances from American Bioproducts Co.

K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER1998-11-12
K971519 — ASSERACHROM TPA TEST KIT1997-08-19
K964716 — STA LIATEST CONTROL [N]+[P] KIT1997-06-26
K964728 — STA-LIATEST D-DI TEST KIT1997-06-26
K964718 — STA D-DI CALIBRATOR KIT1997-05-23

Recalls naming K922021

K-number listed on FDA's recall record

Z-0737-2020 — STA UNICALIBRATOR (ref. 00675)Class II·Terminated·Diagnostica Stago, Inc.·20191118

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K922021.

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