Accuprobe Cryptococcus Neoformans Culture Test
FDA 510(k) K903556 · Gen-Probe, Inc.
510(k) numberK903556
Submission
- Device name
- Accuprobe Cryptococcus Neoformans Culture Test
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- August 7, 1990
- Decision date
- October 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MDE – Dna-Probe, Reagents, Cryptococcal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3165
- Specialty
- Microbiology
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Questions and answers
When was Accuprobe Cryptococcus Neoformans Culture Test cleared by the FDA?
Accuprobe Cryptococcus Neoformans Culture Test (K903556) received a 510(k) decision of Substantially Equivalent on October 2, 1990, 56 days after the submission was received.
What is the product code of K903556?
The FDA product code is MDE – Dna-Probe, Reagents, Cryptococcal, a Class II (moderate risk) device regulated under 21 CFR 866.3165.