510(k) K781103
K781103 is an FDA 510(k) premarket notification submitted by Medishield, Inc. for the device "SPECTRASCAN". The FDA issued a decision of Substantially Equivalent on September 27, 1978. The device falls under product code DAT (Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7340. Medishield, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 27, 1978
- Date Received
- July 3, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 864.7340
- Review Panel
- HE
- Submission Type