STA-LIATEST D-DI TEST KIT— 510(k) K964728

Name: FDA 510(k) clearance K964728
Creator: U.S. Food and Drug Administration
Published: 1997-06-26

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K964728 for STA-LIATEST D-DI TEST KIT, Substantially Equivalent on 1997-06-26. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code DAP
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1996-11-25
Decision date: 1997-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parisppany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DAP

view all

K253985 — INNOVANCE® D-Dimer 2.0 (SMN 10873803)2026-08-11
K172903 — HemosIL D-Dimer HS 5002017-11-22
K162227 — STA® - Liatest® D-Di2016-12-10
K160885 — HemosIL D-Dimer HS2016-10-27
K151534 — HemosIL D-Dimer HS2015-07-06

More clearances from American Bioproducts Co.

view all

K983460 — STAR AUTOMATED MULTI-PARAMETRIC ANALYZER1998-11-12
K971519 — ASSERACHROM TPA TEST KIT1997-08-19
K964716 — STA LIATEST CONTROL [N]+[P] KIT1997-06-26
K964718 — STA D-DI CALIBRATOR KIT1997-05-23
K962675 — STA - LIATEST VWF TEST KIT1996-10-25

Recalls naming K964728

K-number listed on FDA's recall record

Z-0205-2026 — Product: STA Liatest D-Di; REF: 00515;Class II·Ongoing·Diagnostica Stago, Inc.·20250912

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964728.

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