STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K871972

Name: FDA 510(k) clearance K871972
Creator: U.S. Food and Drug Administration
Published: 1987-07-21

Substantially Equivalent

American Dade

FDA 510(k) clearance K871972 for STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1987-07-21. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code DGE
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1987-05-21
Decision date: 1987-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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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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