The following data is part of a premarket notification filed by Trek Diagnostic Systems, Ltd. with the FDA for Sensititre Optiread.
| Device ID | K110583 |
| 510k Number | K110583 |
| Device Name: | SENSITITRE OPTIREAD |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Contact | Cynthia C Knapp |
| Correspondent | Cynthia C Knapp TREK DIAGNOSTIC SYSTEMS, LTD. 982 KEYNOTE CIRCLE SUITE 6 Cleveland, OH 44131 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-01 |
| Decision Date | 2011-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838074530 | K110583 | 000 |
| 05032384474530 | K110583 | 000 |