STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K873051

Name: FDA 510(k) clearance K873051
Creator: U.S. Food and Drug Administration
Published: 1987-10-20

Substantially Equivalent

American Dade

FDA 510(k) clearance K873051 for STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1987-10-20. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code CGJ
Device class: Class 1
Regulation: 21 CFR 862.1300
Advisory panel: Clinical Chemistry
Date received: 1987-08-04
Decision date: 1987-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from American Dade

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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
K872196 — AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III1987-07-31

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