STRATUS PRIMIDONE FLOROMETRIC ENZY— 510(k) K842196

Name: FDA 510(k) clearance K842196
Creator: U.S. Food and Drug Administration
Published: 1984-07-11

Substantially Equivalent

American Dade

FDA 510(k) clearance K842196 for STRATUS PRIMIDONE FLOROMETRIC ENZY, Substantially Equivalent on 1984-07-11. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code LFT
Device class: Class 2
Regulation: 21 CFR 862.3680
Advisory panel: Clinical Toxicology
Date received: 1984-06-04
Decision date: 1984-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFT

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K895567 — PRIMIDONE (FPIA) KIT1989-10-20
K852318 — COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS1985-06-25
K823741 — ADVANCE EMIT-AED PRIMEDONE ASSAY1983-01-07

More clearances from American Dade

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K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
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

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