510(k) K991942
K991942 is an FDA 510(k) premarket notification submitted by Cogent Diagnotics , Ltd. for the device "AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA". The FDA issued a decision of Substantially Equivalent on August 24, 1999. The device falls under product code MLE (Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control), a Class II device regulated under 21 CFR 866.5110. Cogent Diagnotics , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1999
- Date Received
- June 9, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5110
- Review Panel
- IM
- Submission Type