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 |