510(k) K781814
- Device
- SULFATE, FIBRIQUIK PROTAMINE
- Applicant
- GENERAL DIAGNOSTICS
- 510(k) number
- K781814
- Product code
- JBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-11-08
- Date received
- 1978-10-26
- Regulation
- 864.7300
- Classification name
- Fibrin Monomer Paracoagulation
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9710666
- 2245451
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JBN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K854015 | FS TEST KIT | American Bioproducts Co. | 1986-03-06 |
Legacy Summary#
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FDA Review#
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