510(k) K880653
- Device
- Hbf Diluent
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K880653
- Product code
- KQI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-04-21
- Date received
- 1988-02-17
- Regulation
- 864.7455
- Classification name
- Assay, Fetal Hemoglobin
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANKS
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 3023162659
- 3002807968
- 8023024
- 3007490412
- 3013513377
- 3006198300
- 1219029
Source Documents#
510(k) summary PDF not indicated by FDA