The following data is part of a premarket notification filed by Diagnostic Hybrids, Inc. with the FDA for Thyretain Tm Tsi Reporter Bioassay.
| Device ID | K092229 |
| 510k Number | K092229 |
| Device Name: | THYRETAIN TM TSI REPORTER BIOASSAY |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Contact | Ronald H Lollar |
| Correspondent | Ronald H Lollar DIAGNOSTIC HYBRIDS, INC. 1055 EAST STATE STREET SUITE 100 Athens, OH 45701 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-23 |
| Decision Date | 2010-05-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30014613331599 | K092229 | 000 |
| 30014613331544 | K092229 | 000 |
| 30014613331582 | K092229 | 000 |
| 30014613331612 | K092229 | 000 |
| 30014613331629 | K092229 | 000 |
| 30014613331636 | K092229 | 000 |
| 30014613331667 | K092229 | 000 |
| 30014613331681 | K092229 | 000 |
| 30014613331483 | K092229 | 000 |
| 30014613331490 | K092229 | 000 |
| 30014613331513 | K092229 | 000 |
| 30014613331520 | K092229 | 000 |
| 30014613331568 | K092229 | 000 |
| 30014613331506 | K092229 | 000 |