K781103 is an FDA 510(k) clearance for the SPECTRASCAN. This device is classified as a Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control (Class II - Special Controls, product code DAT).
Submitted by Medishield, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1978, 86 days after receiving the submission on July 3, 1978.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 864.7340.
| 510(k) Number | K781103 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 1978 |
| Decision Date | September 27, 1978 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | DAT — Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7340 |