DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET— 510(k) K872360

Name: FDA 510(k) clearance K872360
Creator: U.S. Food and Drug Administration
Published: 1987-07-06

Substantially Equivalent

American Dade

FDA 510(k) clearance K872360 for DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET, Substantially Equivalent on 1987-07-06. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code GHH
Device class: Class 2
Regulation: 21 CFR 864.7320
Advisory panel: Hematology
Date received: 1987-06-18
Decision date: 1987-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, 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

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