The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Isolab's T4 Test Kit.
| Device ID | K951014 |
| 510k Number | K951014 |
| Device Name: | ISOLAB'S T4 TEST KIT |
| Classification | Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine |
| Applicant | ISOLAB, INC. BOX 4350 Akron, OH 44321 |
| Contact | Janet D Perkins |
| Correspondent | Janet D Perkins ISOLAB, INC. BOX 4350 Akron, OH 44321 |
| Product Code | KLI |
| CFR Regulation Number | 862.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1996-10-18 |
| Summary: | summary |