510(k) K954784
- Device
- DRYSIDE NEISSERIA
- Applicant
- DIFCO LABORATORIES, INC.
- 510(k) number
- K954784
- Product code
- LTS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-01-30
- Date received
- 1995-10-17
- Regulation
- 866.2660
- Classification name
- Test Reagents, Neisseria Gonorrhoeae Biochemical
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID W GATES
- Address
- 17197 N. Laurel Park Suite 400 Livouia MI US 48152 48152
Source Documents#
Legacy Summary#
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FDA Review#
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