The following data is part of a premarket notification filed by Becton, Dickinson & Co. with the FDA for Bd Probetec Et Legionella Pneumophila (lp) Amplified Dna Assay.
| Device ID | K033861 |
| 510k Number | K033861 |
| Device Name: | BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY |
| Classification | Dna-reagents, Legionella |
| Applicant | BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Contact | Colleen A Kistler |
| Correspondent | Colleen A Kistler BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks, MD 21152 -0999 |
| Product Code | LQH |
| CFR Regulation Number | 866.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-12 |
| Decision Date | 2004-03-09 |
| Summary: | summary |