510(k) K860498
- Device
- GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM
- Applicant
- GEN-PROBE, INC.
- 510(k) number
- K860498
- Product code
- LQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-07-16
- Date received
- 1986-02-10
- Regulation
- 866.3300
- Classification name
- Dna-reagents, Legionella
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KACIAN, PH.D.
- Address
- 9620 Chesapeake Dr. San Diego CA US 92123 92123
FDA Registration Numbers#
- 3026312356
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LQH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033861 | BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY | Becton, Dickinson & CO | 2004-03-09 |
Legacy Summary#
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FDA Review#
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