ASSERACHROM PF4 KIT— 510(k) K862774

Substantially Equivalent

American Bioproducts Co.

FDA 510(k) clearance K862774 for ASSERACHROM PF4 KIT, Substantially Equivalent on 1986-09-04. Applicant: American Bioproducts Co.. Device class: 2.

Clearance details

Applicant: American Bioproducts Co.
Product code: Code LCO
Device class: Class 2
Regulation: 21 CFR 864.7695
Advisory panel: Hematology
Date received: 1986-07-22
Decision date: 1986-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCO

K243374 — HemosIL CL HIT-IgG(PF4-H)2025-01-28
K201570 — PF4 Enhanced assay2020-09-11
K201311 — PF4 IgG assay2020-06-18
K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls2017-09-08
K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls2016-07-08

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.