510(k) K896859
- Device
- ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K896859
- Product code
- MBT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-02-01
- Date received
- 1989-12-05
- Regulation
- 866.3320
- Classification name
- Dna-probe, Reagent, Histoplasma Capsulatum
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- BRUNI, PHD
- Address
- 9880 Campus Pt. Dr. San Diego CA US 92121 92121
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 15420045506213 | ACCUPROBE | Hologic, Inc. | 2016-04-15 |
Legacy Summary
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FDA Review
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