The following data is part of a premarket notification filed by Life Technologies Corporation with the FDA for Quantstudio Dx Real-time Pcr Instrument.
| Device ID | K123955 |
| 510k Number | K123955 |
| Device Name: | QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | LIFE TECHNOLOGIES CORPORATION 5791 Van Allen Way Carlsbad, CA 92008 |
| Contact | Deanna Vella |
| Correspondent | Deanna Vella LIFE TECHNOLOGIES CORPORATION 5791 Van Allen Way Carlsbad, CA 92008 |
| Product Code | OOI |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-21 |
| Decision Date | 2013-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190302000765 | K123955 | 000 |
| 10190302015615 | K123955 | 000 |
| 10190302006729 | K123955 | 000 |
| 10190302000376 | K123955 | 000 |
| 10190302000383 | K123955 | 000 |
| 10190302000390 | K123955 | 000 |
| 10190302000420 | K123955 | 000 |
| 10190302000437 | K123955 | 000 |
| 10190302000468 | K123955 | 000 |
| 10190302000505 | K123955 | 000 |
| 10190302000598 | K123955 | 000 |
| 10190302000611 | K123955 | 000 |
| 10190302000697 | K123955 | 000 |
| 10190302000734 | K123955 | 000 |
| 10190302000710 | K123955 | 000 |