510(k) K891299
- Device
- Mid-level Igg Kit Cat. No. 9315
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K891299
- Product code
- DAQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-03-22
- Date received
- 1989-03-13
- Regulation
- 866.5540
- Classification name
- Igg (Fd Fragment Specific), Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- 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
Source Documents#
510(k) summary PDF not indicated by FDA