510(k) K981592
K981592 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "ACS:CENTAUR AFP". The FDA issued a decision of Substantially Equivalent on July 7, 1998. The device falls under product code LOQ (Device, General Purpose, Hematology), a Class II device regulated under 21 CFR 866.6010. Chiron Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1998
- Date Received
- May 4, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, General Purpose, Hematology
- Device Class
- Class II
- Regulation Number
- 866.6010
- Review Panel
- HE
- Submission Type