THROMBIN TIME TEST— 510(k) K822466

Substantially Equivalent

American Dade

FDA 510(k) clearance K822466 for THROMBIN TIME TEST, Substantially Equivalent on 1982-09-14. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code GJA
Device class: Class 2
Regulation: 21 CFR 864.7875
Advisory panel: Hematology
Date received: 1982-08-16
Decision date: 1982-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K970645 — BC THROMBIN REAGENT1997-05-19
K925493 — BIOMERIEUX HEMOLAB THROMBICALCI-TEST1994-04-21
K930157 — TEST THROMBIN1993-05-14

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.