510(k) K821092
K821092 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "GAMMADAB[125]EGE RADIOIMMUNOASSAY IT". The FDA issued a decision of Substantially Equivalent on June 22, 1982. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 1982
- Date Received
- April 19, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ige, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type