Accuprobe Haeomphilus Influenzae Culture
FDA 510(k) K897079 · Gen-Probe, Inc.
510(k) numberK897079
Submission
- Device name
- Accuprobe Haeomphilus Influenzae Culture
- Applicant
- Gen-Probe, Inc.
San Diego, CA, US - Received
- December 22, 1989
- Decision date
- March 8, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MCC – Dna-Probe, Haemophilus Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Specialty
- Microbiology
Other 510(k)s with product code MCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K901397 | Accuprobe Listeria Monocytogenes Culture Confirma.MCC · Traditional | Gen-Probe, Inc. | 06/20/1990SE |
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Questions and answers
When was Accuprobe Haeomphilus Influenzae Culture cleared by the FDA?
Accuprobe Haeomphilus Influenzae Culture (K897079) received a 510(k) decision of Substantially Equivalent on March 8, 1990, 76 days after the submission was received.
What is the product code of K897079?
The FDA product code is MCC – Dna-Probe, Haemophilus Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3300.