The following data is part of a premarket notification filed by In Vitro Diagnostics, Inc. with the FDA for T Uptake Enzyme Immunoassay Crimped Tube Kit.
| Device ID | K896925 |
| 510k Number | K896925 |
| Device Name: | T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT |
| Classification | Radioassay, Triiodothyronine Uptake |
| Applicant | IN VITRO DIAGNOSTICS, INC. 8100 SOUTHPARK WAY BLDG. B STE.1 Littleton, CO 80120 |
| Contact | James Musick |
| Correspondent | James Musick IN VITRO DIAGNOSTICS, INC. 8100 SOUTHPARK WAY BLDG. B STE.1 Littleton, CO 80120 |
| Product Code | KHQ |
| CFR Regulation Number | 862.1715 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-12 |
| Decision Date | 1990-01-18 |