510(k) K903201
K903201 is an FDA 510(k) premarket notification submitted by Gen-Probe, Inc. for the device "ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code MDC (Dna-Probe - Blastomyces Dermatitidis), a Class II device regulated under 21 CFR 866.3060. Gen-Probe, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1990
- Date Received
- July 20, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dna-Probe - Blastomyces Dermatitidis
- Device Class
- Class II
- Regulation Number
- 866.3060
- Review Panel
- MI
- Submission Type