STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.— 510(k) K860140

Name: FDA 510(k) clearance K860140
Creator: U.S. Food and Drug Administration
Published: 1986-02-06

Substantially Equivalent

American Dade

FDA 510(k) clearance K860140 for STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO., Substantially Equivalent on 1986-02-06. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code LAN
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 1986-01-14
Decision date: 1986-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LAN

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K060738 — TDM N-ACETYLPROCAINAMIDE2006-08-16
K032564 — DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF1112003-10-31
K011620 — EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N2292001-06-18
K983812 — NAPA EIA ASSAY1998-11-16
K971713 — N-ACETYLPROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM1997-06-11

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

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