Accuprobe Blastomyces Dermatit Cult Confirm Test
FDA 510(k) K903201 · Gen-Probe, Inc.
510(k) numberK903201
Submission
- Device name
- Accuprobe Blastomyces Dermatit Cult Confirm Test
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- July 20, 1990
- Decision date
- September 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MDC – Dna-Probe - Blastomyces Dermatitidis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3060
- Specialty
- Microbiology
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Questions and answers
When was Accuprobe Blastomyces Dermatit Cult Confirm Test cleared by the FDA?
Accuprobe Blastomyces Dermatit Cult Confirm Test (K903201) received a 510(k) decision of Substantially Equivalent on September 12, 1990, 54 days after the submission was received.
What is the product code of K903201?
The FDA product code is MDC – Dna-Probe - Blastomyces Dermatitidis, a Class II (moderate risk) device regulated under 21 CFR 866.3060.