510(k) K771588
- Device
- PLATELET CONTROLS NORMAL & ABNORMAL
- Applicant
- Dade, Baxter Travenol Diagnostics, Inc.
- 510(k) number
- K771588
- Product code
- GJP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-25
- Date received
- 1977-08-18
- Regulation
- 864.8625
- Classification name
- Control, Platelet
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9613959
- 3014150341
- 3009711478
- 1950302
Source Documents#
510(k) summary PDF not indicated by FDA