The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Probetec Herpes Simplex Viruses (hsv 1& 2) Q Amplified Dna Assays.
| Device ID | K103798 |
| 510k Number | K103798 |
| Device Name: | BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | BECTON DICKINSON & CO. 7 LOVETON CIR. Baltimore, MD 21152 |
| Contact | Thalia Charles |
| Correspondent | Thalia Charles BECTON DICKINSON & CO. 7 LOVETON CIR. Baltimore, MD 21152 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904417499 | K103798 | 000 |
| 00382904417482 | K103798 | 000 |