The following data is part of a premarket notification filed by Spartan Bioscience Inc with the FDA for Spartan Rx Cyp2c19 Test System.
| Device ID | K123891 |
| 510k Number | K123891 |
| Device Name: | SPARTAN RX CYP2C19 TEST SYSTEM |
| Classification | Drug Metabolizing Enzyme Genotyping Systems |
| Applicant | SPARTAN BIOSCIENCE INC 3 LAGOON DRIVE, STE 280 Redwood Shores, CA 94065 |
| Contact | Lorry Huffman |
| Correspondent | Lorry Huffman SPARTAN BIOSCIENCE INC 3 LAGOON DRIVE, STE 280 Redwood Shores, CA 94065 |
| Product Code | NTI |
| CFR Regulation Number | 862.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-18 |
| Decision Date | 2013-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628055420101 | K123891 | 000 |
| 00628055420095 | K123891 | 000 |
| 00628055420088 | K123891 | 000 |
| 00628055420071 | K123891 | 000 |
| 00628055420057 | K123891 | 000 |
| 00628055420040 | K123891 | 000 |
| 00628055420033 | K123891 | 000 |
| 00628055420026 | K123891 | 000 |
| 00628055420019 | K123891 | 000 |