Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer
FDA 510(k) K971418 · Chiron Diagnostics Corp.
510(k) numberK971418
Submission
- Device name
- Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer
- Applicant
- Chiron Diagnostics Corp.
Medfield, MA, US - Received
- April 16, 1997
- Decision date
- July 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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More from Fujirebio Diagnostics,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 |
| K974325 | Chiron Diagnostics ACS:180 MyoglobinDDR · Traditional | 12/08/1997SE |
Questions and answers
When was Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer cleared by the FDA?
Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer (K971418) received a 510(k) decision of Substantially Equivalent on July 17, 1997, 92 days after the submission was received.
What is the product code of K971418?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.