510(k) K992502
K992502 is an FDA 510(k) premarket notification submitted by Axis for the device "AXIS %CDT TURBIDIMETRIC IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on December 21, 1999. The device falls under product code NAO (Test, Carbohydrate Deficient Transferrin), a Class I device regulated under 21 CFR 862.1360.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1999
- Date Received
- July 26, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Carbohydrate Deficient Transferrin
- Device Class
- Class I
- Regulation Number
- 862.1360
- Review Panel
- CH
- Submission Type