510(k) K874373
- Device
- Pt Pro-clot
- Applicant
- PROBE-TEK, INC.
- 510(k) number
- K874373
- Product code
- JBR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-01-05
- Date received
- 1987-10-26
- Regulation
- 864.7525
- Classification name
- Test, Heparin Neutralization
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- FRANK LYMAN
- Address
- 3010 S. Washington Ave. Lansing MI US 48910 48910
FDA Registration Numbers#
- 9610806
Source Documents#
510(k) summary PDF not indicated by FDA