PROTOPATH FACTOR VIII ASSAY— 510(k) K834051

Substantially Equivalent

American Dade

FDA 510(k) clearance K834051 for PROTOPATH FACTOR VIII ASSAY, Substantially Equivalent on 1984-02-04. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code GGP
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1983-11-23
Decision date: 1984-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.