510(k) K761304
- Device
- JTB 700 HEMATOLOGY ANALYZER
- Applicant
- J.T. Baker Chemical Co.
- 510(k) number
- K761304
- Product code
- JPJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-02-01
- Date received
- 1976-12-22
- Regulation
- 864.5300
- Classification name
- Red-Cell Indices, Calculated
- 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
Source Documents#
510(k) summary PDF not indicated by FDA