The following data is part of a premarket notification filed by In Vitro Diagnostics, Inc. with the FDA for Follicle Stimulating Hormone-eia-xt.
| Device ID | K896864 |
| 510k Number | K896864 |
| Device Name: | FOLLICLE STIMULATING HORMONE-EIA-XT |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | IN VITRO DIAGNOSTICS, INC. 8100 SOUTHPARK WAY BLDG. B STE.1 Littleton, CO 80120 |
| Contact | Musick, Ph.d. |
| Correspondent | Musick, Ph.d. IN VITRO DIAGNOSTICS, INC. 8100 SOUTHPARK WAY BLDG. B STE.1 Littleton, CO 80120 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-06 |
| Decision Date | 1990-01-11 |