STRATUS LIDOCAINE FLUOROMETRIC ENZYME— 510(k) K843184

Name: FDA 510(k) clearance K843184
Creator: U.S. Food and Drug Administration
Published: 1984-09-26

Substantially Equivalent

American Dade

FDA 510(k) clearance K843184 for STRATUS LIDOCAINE FLUOROMETRIC ENZYME, Substantially Equivalent on 1984-09-26. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KLR
Device class: Class 2
Regulation: 21 CFR 862.3555
Advisory panel: Clinical Toxicology
Date received: 1984-08-13
Decision date: 1984-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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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