510(k) K992157
K992157 is an FDA 510(k) premarket notification submitted by Chiron Diagnostics Corp. for the device "CHIRON DIAGNOSTICS ACS: 180 FERRITIN ASSAY". The FDA issued a decision of Substantially Equivalent on August 5, 1999. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Chiron Diagnostics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1999
- Date Received
- June 25, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ferritin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5340
- Review Panel
- IM
- Submission Type