Acs:Centaur Afp
FDA 510(k) K981592 · Chiron Diagnostics Corp.
510(k) numberK981592
Submission
- Device name
- Acs:Centaur Afp
- Applicant
- Chiron Diagnostics Corp.
Medfield, MA, US - Received
- May 4, 1998
- Decision date
- July 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOQ – Device, General Purpose, Hematology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
More from Chiron Diagnostics Corp.
| 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 |
| 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 |
| K970695 | ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen…MOI · Traditional | 08/08/1997SE |
Questions and answers
When was Acs:Centaur Afp cleared by the FDA?
Acs:Centaur Afp (K981592) received a 510(k) decision of Substantially Equivalent on July 7, 1998, 64 days after the submission was received.
What is the product code of K981592?
The FDA product code is LOQ – Device, General Purpose, Hematology, a Class II (moderate risk) device regulated under 21 CFR 866.6010.