ASSERACHROM IX:AG— 510(k) K854312

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K854312 for ASSERACHROM IX:AG, Substantially Equivalent on 1986-02-04. 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: 1985-10-28
Decision date: 1986-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GGP

K251440 — CRYOcheck Chromogenic Factor VIII2025-08-25
K230852 — HemosIL Chromogenic Factor IX2023-12-13
K220728 — vWF Ag2023-06-02
K214002 — CRYOcheck Chromogenic Factor IX2022-12-23
K223402 — HemosIL von Willebrand Factor Antigen2022-12-09

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

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