STRATUS GENTAMICIN FLUOROMETRIC ENZYM— 510(k) K832445

Name: FDA 510(k) clearance K832445
Creator: U.S. Food and Drug Administration
Published: 1983-08-31

Substantially Equivalent

American Dade

FDA 510(k) clearance K832445 for STRATUS GENTAMICIN FLUOROMETRIC ENZYM, Substantially Equivalent on 1983-08-31. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1983-07-25
Decision date: 1983-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCD

view all

K243500 — ARCHITECT iGentamicin2025-07-09
K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS2011-04-01
K060709 — MULTIGENT GENTAMICIN2006-06-15
K042479 — VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 142005-01-06
K020704 — ROCHE ONLINE GENTAMICIN2002-07-12

More clearances from American Dade

view all

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.