STRATUS AMIKACIN FLUOROMETRIC— 510(k) K832336

Substantially Equivalent

American Dade

FDA 510(k) clearance K832336 for STRATUS AMIKACIN FLUOROMETRIC, Substantially Equivalent on 1983-08-31. Applicant: American Dade. Device class: 2.

Clearance details

Applicant: American Dade
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1983-07-18
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 KLQ

K052815 — QMS AMIKACIN REAGENTS2005-11-01
K033884 — RANDOX AMIKACIN2004-06-09
K955570 — INNOFLUOR AMIKACIN ASSAY SYSTEM1996-02-09
K903100 — INNOFLUOR (TM) AMIKACIN REAGENT SET1990-08-09
K894517 — FPR AMIKACIN KIT1989-09-28

More clearances from American Dade

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.