CLOTTING TIME REAGENT— 510(k) K820084

Substantially Equivalent

American Dade

FDA 510(k) clearance K820084 for CLOTTING TIME REAGENT, Substantially Equivalent on 1982-02-22. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code GJB
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1982-01-12
Decision date: 1982-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.