Acs Digitoxin

FDA 510(k) K970546 · Chiron Diagnostics Corp.

Substantially Equivalent

510(k) numberK970546

Submission

Device name
Acs Digitoxin
Applicant
Chiron Diagnostics Corp.
Medfield, MA, US
Received
February 12, 1997
Decision date
July 14, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LFM – Enzyme Immunoassay, Digitoxin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3300
Specialty
Clinical Toxicology

Other 510(k)s with product code LFM

510(k)DeviceApplicantDecision
K062024Dimension Vista Digitoxin, Digoxin, Gentamicin, N-Acetylprocainamide, Phenytoin…LFM · Special Dade Behring, Inc.07/28/2006SE
K012112Randox DigitoxinLFM · Traditional Randox Laboratories, Ltd.01/11/2002SE
K990251DGTX Flex Reagent Cartridge, Model DF36LFM · Traditional Dade Behring, Inc.03/31/1999SE
K963158Abbott Axsym Digitoxin (Modify)LFM · Traditional Abbott Laboratories09/10/1996SE
K954420Axsym DigitoxinLFM · Traditional Abbott Laboratories12/29/1995SE
K951631Digoxin Assay for the Tecchnicon Ra/Opera Systems In-Vitro Diagnostic SystemsLFM · Traditional Bayer Corp.06/09/1995SE
K943235Immulite DigitoxinLFM · Traditional Diagnostic Products Corp.10/27/1994SE
K942610Kodak Extachem Clinical Chemistry Slide Digoxin (DGXN)LFM · Traditional Eastman Kodak Company10/20/1994SE
K942619Emit 2000 Digoxin Assay/CalibratorsLFM · Traditional Syva Co.09/20/1994SE
K915465Digitoxin Fpia Reagent SetLFM · Traditional Sigma Diagnostics, Inc.01/27/1992SE

More from Sigma Diagnostics, Inc.

510(k)DeviceDecision
K992157Chiron Diagnostics Acs: 180 Ferritin AssayDBF · Traditional 08/05/1999SE
K991582Chiron Diagnostics Acs: 180 FolateCGN · Traditional 06/30/1999SE
K991692Chiron Diagnostics Acs: 180 FT3CDP · Traditional 06/18/1999SE
K982680Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayMOI · Traditional 10/15/1998SE
K981839Acs:Centaur PSA2 ImmunoassayLTJ · Traditional 08/12/1998SE
K981478Acs:Centaur CeaDHX · Traditional 08/12/1998SE
K981592Acs:Centaur AfpLOQ · Traditional 07/07/1998SE
K980528Chiron Diagnostics ACS:180 Troponin I Assay (Ctni)MMI · Traditional 03/03/1998SE
K974029Acs TobramycinLCR · Traditional 02/12/1998SE
K974325Chiron Diagnostics ACS:180 MyoglobinDDR · Traditional 12/08/1997SE

Questions and answers

When was Acs Digitoxin cleared by the FDA?

Acs Digitoxin (K970546) received a 510(k) decision of Substantially Equivalent on July 14, 1997, 152 days after the submission was received.

What is the product code of K970546?

The FDA product code is LFM – Enzyme Immunoassay, Digitoxin, a Class II (moderate risk) device regulated under 21 CFR 862.3300.