BD Probetec Et Legionella Pneumophila (LP) Amplified DNA Assay
FDA 510(k) K033861 · Becton, Dickinson & CO
510(k) numberK033861
Submission
- Device name
- BD Probetec Et Legionella Pneumophila (LP) Amplified DNA Assay
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- December 12, 2003
- Decision date
- March 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LQH – Dna-Reagents, Legionella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Specialty
- Microbiology
Other 510(k)s with product code LQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K860498 | Gen-Probe Legionella Rapid Diagnostic SystemLQH · Traditional | Gen-Probe, Inc. | 07/16/1986SE |
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Questions and answers
When was BD Probetec Et Legionella Pneumophila (LP) Amplified DNA Assay cleared by the FDA?
BD Probetec Et Legionella Pneumophila (LP) Amplified DNA Assay (K033861) received a 510(k) decision of Substantially Equivalent on March 9, 2004, 88 days after the submission was received.
What is the product code of K033861?
The FDA product code is LQH – Dna-Reagents, Legionella, a Class II (moderate risk) device regulated under 21 CFR 866.3300.