The following data is part of a premarket notification filed by Applied Biosystems with the FDA for Assay, Genotype, Hiv Drug Resistance, In Vitro.
| Device ID | BK010024 |
| 510k Number | BK010024 |
| Device Name: | Assay, Genotype, HIV Drug Resistance, In Vitro |
| Classification | Assay, Genotype, Hiv Drug Resistance, In Vitro |
| Applicant | Applied Biosystems 850 Lincoln Centre Drive Foster City, CA 94404 |
| Product Code | NHS |
| CFR Regulation Number | 866.3950 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-12 |
| Decision Date | 2002-12-10 |