510(k) K033861
- Device
- BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY
- Applicant
- BECTON, DICKINSON & CO.
- 510(k) number
- K033861
- Product code
- LQH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-03-09
- Date received
- 2003-12-12
- Regulation
- 866.3300
- Classification name
- Dna-reagents, Legionella
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- COLLEEN A KISTLER
- Address
- 7loveton Cir. Sparks MD US 21152 21152
FDA Registration Numbers#
- 3026312356
Source Documents#
Other 510(k) Records For Product Code LQH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K860498 | GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM | Gen-Probe, Inc. | 1986-07-16 |
Legacy Summary#
summary
FDA Review#
Decision Summary