THROMBOKINETIC FIBRINOGEN ASSAY— 510(k) K792563

Substantially Equivalent

Bio/Data Corp.

FDA 510(k) clearance K792563 for THROMBOKINETIC FIBRINOGEN ASSAY, Substantially Equivalent on 1980-01-11. Applicant: Bio/Data Corp.. Device class: 2.

Clearance details

Applicant: Bio/Data Corp.
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1979-12-12
Decision date: 1980-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KQJ

K251968 — HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XL2025-07-24
K073367 — HEMOSIL FIBRINOGEN-C2007-12-27
K050928 — DADE THROMBIN REAGENT2005-06-29
K971858 — SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)1997-10-09
K970189 — FIF TM1997-05-21

More clearances from Bio/Data Corp.

K001891 — MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C2000-07-12
K943153 — MICROSAMPLE COAGULATION ANALYZER1995-03-24
K893650 — PLATELET AGGREGATION PROFILER MODEL PAP-4C1989-06-23
K881150 — KINETIC FIBRINOGEN ASSAY1988-03-28
K873382 — PLATELET EXTRACT REAGENT1987-11-20

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