510(k) K903556
- Device
- ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K903556
- Product code
- MDE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-10-02
- Date received
- 1990-08-07
- Regulation
- 866.3165
- Classification name
- Dna-probe, Reagents, Cryptococcal
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CONNIE KIRBY
- Address
- 9880 Campus Pt. Dr. San Diego CA US 92121 92121
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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