STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO.— 510(k) K870158

Name: FDA 510(k) clearance K870158
Creator: U.S. Food and Drug Administration
Published: 1987-03-19

Substantially Equivalent

American Dade

FDA 510(k) clearance K870158 for STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO., Substantially Equivalent on 1987-03-19. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code CEC
Device class: Class 2
Regulation: 21 CFR 862.1695
Advisory panel: Clinical Chemistry
Date received: 1987-01-13
Decision date: 1987-03-19
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

Adverse events under product code CEC

product code CEC

Malfunction: 899
Total: 899

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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