The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Tigris Dts Automated Analyzer For Automating Amplified Nucleic Acid Test Assays.
| Device ID | K032194 |
| 510k Number | K032194 |
| Device Name: | TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS |
| Classification | Dna-reagents, Neisseria |
| Applicant | GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Contact | Wayne A Kvetkosky |
| Correspondent | Wayne A Kvetkosky GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego, CA 92121 -4362 |
| Product Code | LSL |
| CFR Regulation Number | 866.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-18 |
| Decision Date | 2003-12-24 |