FIBRINOGEN CONTROL PLASMA— 510(k) K811069

Substantially Equivalent

American Dade

FDA 510(k) clearance K811069 for FIBRINOGEN CONTROL PLASMA, Substantially Equivalent on 1981-07-10. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KQJ
Device class: Class 2
Regulation: 21 CFR 864.7340
Advisory panel: Hematology
Date received: 1981-04-20
Decision date: 1981-07-10
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 American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

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