510(k) K897079
- Device
- ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K897079
- Product code
- MCC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-03-08
- Date received
- 1989-12-22
- Regulation
- 866.3300
- Classification name
- Dna-probe, Haemophilus Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRUNI, PH.D.
- Address
- 9880 Campus Pt. Dr. San Diego CA US 92121 92121
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MCC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K901397 | ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA. | Gen-Probe, Inc. | 1990-06-20 |
Legacy Summary#
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FDA Review#
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