ONLINE TDM AMIKA— 510(k) K032279

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K032279 for ONLINE TDM AMIKA, Substantially Equivalent on 2003-10-10. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code KLP
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 2003-07-24
Decision date: 2003-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLP

K873426 — EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 166451987-10-29
K790899 — BACTEC1979-05-23
K780949 — BIO-MONITOR AMIKACIN1978-08-14

More clearances from Roche Diagnostics Corp.

K130138 — SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM2013-03-15
K101365 — ELECSYS CA 19-9 CALCHECK 52010-10-05
K100853 — COBAS 8000 MODULAR SERIES ANALYZER2010-09-09
K101196 — ACCU-CHEK ULTRFLEX INFUSION SET2010-08-27
K093664 — AMPHETAMINES II ASSAY2010-07-28

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