510(k) K854015
- Device
- FS TEST KIT
- Applicant
- AMERICAN BIOPRODUCTS CO.
- 510(k) number
- K854015
- Product code
- JBN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-06
- Date received
- 1985-09-27
- 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#
- Contact
- B LE
- Address
- 601 N. Jefferson Rd. Parsippany NJ US 07054 07054
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 |
|---|---|---|---|
| K781814 | SULFATE, FIBRIQUIK PROTAMINE | General Diagnostics | 1978-11-08 |
Legacy Summary#
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FDA Review#
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