Chiron Diagnostics ACS:180 Myoglobin
FDA 510(k) K974325 · Chiron Diagnostics Corp.
510(k) numberK974325
Submission
- Device name
- Chiron Diagnostics ACS:180 Myoglobin
- Applicant
- Chiron Diagnostics Corp.
Medfield, MA, US - Received
- November 18, 1997
- Decision date
- December 8, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDR – Myoglobin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5680
- Specialty
- Immunology
Other 510(k)s with product code DDR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231832 | Access MyoglobinDDR · Traditional | Beckman Coulter, Inc. | 09/18/2023SE |
| K123785 | Diazyme Myoglobin; Assay, Calibrator Set, Control SetDDR · Traditional | Diazyme Laboratories | 06/07/2013SE |
| K122599 | Advia Chemistry Myoglobin Reagent, Advia Chemistry Myoglbin CalibratorDDR · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/03/2012SE |
| K083260 | Elecsys Myoglobin Stat, and Elecsys MyoglobinDDR · Traditional | Roche Diagnostics | 10/16/2009SE |
| K080481 | Access Immunoassay Systems Myoglobin and Access Immunoassay Systems Myoglobin CalibratorsDDR · Traditional | Beckman Coulter, Inc. | 02/20/2009SE |
| K061683 | Tina-Quant Myoglobin GEN.2 Test SystemDDR · Traditional | Roche Diagnostics Corp. | 07/21/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | Fisher Diagnostics | 01/24/2005SE |
| K042982 | Quantex MyoglobinDDR · Traditional | Instrumentation Laboratory CO | 12/22/2004SE |
| K033300 | Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersDDR · Traditional | Ortho-Clinical Diagnostics, Inc. | 11/05/2003SE |
| K021229 | Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…DDR · Traditional | Beckman Coulter, Inc. | 06/28/2002SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992157 | Chiron Diagnostics Acs: 180 Ferritin AssayDBF · Traditional | 08/05/1999SE |
| K991582 | Chiron Diagnostics Acs: 180 FolateCGN · Traditional | 06/30/1999SE |
| K991692 | Chiron Diagnostics Acs: 180 FT3CDP · Traditional | 06/18/1999SE |
| K982680 | Chiron Diagnostics Corporation Acs: Centaur BR ImmunoassayMOI · Traditional | 10/15/1998SE |
| K981839 | Acs:Centaur PSA2 ImmunoassayLTJ · Traditional | 08/12/1998SE |
| K981478 | Acs:Centaur CeaDHX · Traditional | 08/12/1998SE |
| K981592 | Acs:Centaur AfpLOQ · Traditional | 07/07/1998SE |
| K980528 | Chiron Diagnostics ACS:180 Troponin I Assay (Ctni)MMI · Traditional | 03/03/1998SE |
| K974029 | Acs TobramycinLCR · Traditional | 02/12/1998SE |
| K970695 | ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…MOI · Traditional | 08/08/1997SE |
Questions and answers
When was Chiron Diagnostics ACS:180 Myoglobin cleared by the FDA?
Chiron Diagnostics ACS:180 Myoglobin (K974325) received a 510(k) decision of Substantially Equivalent on December 8, 1997, 20 days after the submission was received.
What is the product code of K974325?
The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.