Accuprobe Coccidioides Immitis Culture Confirm.
FDA 510(k) K904047 · Gen-Probe, Inc.
510(k) numberK904047
Submission
- Device name
- Accuprobe Coccidioides Immitis Culture Confirm.
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- September 4, 1990
- Decision date
- October 2, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MDF – Dna-Probe, Reagents, Coccidioides Immitis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3135
- Specialty
- Microbiology
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Questions and answers
When was Accuprobe Coccidioides Immitis Culture Confirm. cleared by the FDA?
Accuprobe Coccidioides Immitis Culture Confirm. (K904047) received a 510(k) decision of Substantially Equivalent on October 2, 1990, 28 days after the submission was received.
What is the product code of K904047?
The FDA product code is MDF – Dna-Probe, Reagents, Coccidioides Immitis, a Class II (moderate risk) device regulated under 21 CFR 866.3135.