The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for 3m Integrated Cycler (110v) & (220v).
| Device ID | K102314 |
| 510k Number | K102314 |
| Device Name: | 3M INTEGRATED CYCLER (110V) & (220V) |
| Classification | Real Time Nucleic Acid Amplification System |
| Applicant | FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST Cypress, CA 90630 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST Cypress, CA 90630 |
| Product Code | OOI |
| CFR Regulation Number | 862.2570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-16 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40816101025082 | K102314 | 000 |
| 10816101025005 | K102314 | 000 |
| 10816101025012 | K102314 | 000 |
| 10816101025029 | K102314 | 000 |
| 10816101025036 | K102314 | 000 |
| 20816101025101 | K102314 | 000 |
| 30816101025078 | K102314 | 000 |
| 30816101025085 | K102314 | 000 |
| 30816101025092 | K102314 | 000 |
| 40816101025075 | K102314 | 000 |
| 10816101025111 | K102314 | 000 |