510(k) K903201
- Device
- ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K903201
- Product code
- MDC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-09-12
- Date received
- 1990-07-20
- Regulation
- 866.3060
- Classification name
- Dna-probe - Blastomyces Dermatitidis
- 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases