The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Abbott M2000sp And Abbott M2000rt, Models 9k14-01 (g-series), 9k14-02 (e-series), 9k1501.
| Device ID | K092705 |
| 510k Number | K092705 |
| Device Name: | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Contact | Paula E Martin |
| Correspondent | Paula E Martin ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018 |
| Product Code | OOI |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-03 |
| Decision Date | 2010-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884999046482 | K092705 | 000 |
| 00884999006515 | K092705 | 000 |
| 00884999006492 | K092705 | 000 |
| 00884999006485 | K092705 | 000 |
| 00884999002883 | K092705 | 000 |
| 00884999001381 | K092705 | 000 |
| 00884999001350 | K092705 | 000 |
| 00884999001343 | K092705 | 000 |
| 00884999001336 | K092705 | 000 |
| 00884999000414 | K092705 | 000 |
| 20884999046478 | K092705 | 000 |
| 20884999046454 | K092705 | 000 |
| 20884999046447 | K092705 | 000 |
| 00884999006522 | K092705 | 000 |
| 00884999006539 | K092705 | 000 |
| 00884999006577 | K092705 | 000 |
| 30884999046475 | K092705 | 000 |
| 30884999046451 | K092705 | 000 |
| 30884999046444 | K092705 | 000 |
| 00884999043503 | K092705 | 000 |
| 00884999043497 | K092705 | 000 |
| 00884999032064 | K092705 | 000 |
| 00884999032057 | K092705 | 000 |
| 00884999031814 | K092705 | 000 |
| 00884999031753 | K092705 | 000 |
| 00884999006911 | K092705 | 000 |
| 00884999006898 | K092705 | 000 |
| 00884999006584 | K092705 | 000 |
| 20884999046485 | K092705 | 000 |