510(k) K781103
- Device
- SPECTRASCAN
- Applicant
- MEDISHIELD, INC.
- 510(k) number
- K781103
- Product code
- DAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-09-27
- Date received
- 1978-07-03
- Regulation
- 864.7340
- Classification name
- Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
- Medical specialty
- Hematology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K924892 | FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM | Organon Teknika Corp. | 1994-04-21 |
Legacy Summary#
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FDA Review#
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