510(k) K791749
K791749 is an FDA 510(k) premarket notification submitted by Clinical Sciences, Inc. for the device "INDIRECT IMMUNO ENZYME,ANTIGEN,CONTROL". The FDA issued a decision of Substantially Equivalent on October 17, 1979. The device falls under product code DAA (Igg, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Clinical Sciences, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 17, 1979
- Date Received
- September 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Igg, Peroxidase, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- PA
- Submission Type