510(k) K810722
K810722 is an FDA 510(k) premarket notification submitted by Clinical Assays, Inc. for the device "GASTRIN RADIOIMMUNOASSAY TEST". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code CGC (Radioimmunoassay, Gastrin), a Class I device regulated under 21 CFR 862.1325. Clinical Assays, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1981
- Date Received
- March 17, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Gastrin
- Device Class
- Class I
- Regulation Number
- 862.1325
- Review Panel
- CH
- Submission Type