AMIKACIN KIT (FPIA)— 510(k) K862248

Substantially Equivalent

Windsor Laboratories, Inc.

FDA 510(k) clearance K862248 for AMIKACIN KIT (FPIA), Substantially Equivalent on 1986-08-04. Applicant: Windsor Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Windsor Laboratories, Inc.
Product code: Code LGJ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1986-06-12
Decision date: 1986-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garland, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGJ

K991597 — COBAS INTEGRA AMIKACIN MAB1999-07-22
K941712 — COBAS-FP REAGENTS AND CALIBRATORS1994-06-13

More clearances from Windsor Laboratories, Inc.

K873281 — CARBAMAZEPINE (FPIA) CALIBRATOR KIT1987-10-28
K873282 — CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY1987-09-22
K871486 — (FPIA) ASSAY BUFFER1987-05-08
K870389 — DIGOXIN (FPIA) CALIBRATOR KIT1987-04-01
K870390 — PHENOBARBITAL (FPIA) CALIBRATOR KIT1987-04-01

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