The following data is part of a premarket notification filed by Intl. Immunoassay Laboratories, Inc. with the FDA for Immunoccult Eia Test Kit.
| Device ID | K871143 |
| 510k Number | K871143 |
| Device Name: | IMMUNOCCULT EIA TEST KIT |
| Classification | Reagent, Occult Blood |
| Applicant | INTL. IMMUNOASSAY LABORATORIES, INC. 1900 WYATT DR., #11 Santa Clara, CA 95054 |
| Contact | Shah, Ph.d. |
| Correspondent | Shah, Ph.d. INTL. IMMUNOASSAY LABORATORIES, INC. 1900 WYATT DR., #11 Santa Clara, CA 95054 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-23 |
| Decision Date | 1988-07-08 |