ACS DIGITOXIN— 510(k) K970546

Substantially Equivalent

Chiron Diagnostics Corp.

FDA 510(k) clearance K970546 for ACS DIGITOXIN, Substantially Equivalent on 1997-07-14. Applicant: Chiron Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Chiron Diagnostics Corp.
Product code: Code LFM
Device class: Class 2
Regulation: 21 CFR 862.3300
Advisory panel: Clinical Toxicology
Date received: 1997-02-12
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFM

K062024 — DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE2006-07-28
K012112 — RANDOX DIGITOXIN2002-01-11
K990251 — DGTX FLEX REAGENT CARTRIDGE, MODEL DF361999-03-31
K963158 — ABBOTT AXSYM DIGITOXIN (MODIFY)1996-09-10
K954420 — AXSYM DIGITOXIN1995-12-29

More clearances from Chiron Diagnostics Corp.

K992157 — CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY1999-08-05
K991582 — CHIRON DIAGNOSTICS ACS: 180 FOLATE1999-06-30
K991692 — CHIRON DIAGNOSTICS ACS: 180 FT31999-06-18
K982680 — CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY1998-10-15
K981478 — ACS:CENTAUR CEA1998-08-12

Recalls naming K970546

K-number listed on FDA's recall record

Z-0510-2013 — Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Intended Use For in vitro diagnostic use in the quantitative determination of digitoxin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems.Class II·Terminated·Siemens Healthcare Diagnostics, Inc·20121114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970546.

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