510(k) K023397
K023397 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT ARCHITECT FOLATE". The FDA issued a decision of Substantially Equivalent on December 16, 2002. The device falls under product code CGN (Acid, Folic, Radioimmunoassay), a Class II device regulated under 21 CFR 862.1295. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2002
- Date Received
- October 9, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Folic, Radioimmunoassay
- Device Class
- Class II
- Regulation Number
- 862.1295
- Review Panel
- CH
- Submission Type