K902360 is an FDA 510(k) clearance for the HEMA-SCREEN. This device is classified as a Reagent, Occult Blood (Class II - Special Controls, product code KHE).
Submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on July 27, 1990, 59 days after receiving the submission on May 29, 1990.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6550.
| 510(k) Number | K902360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 1990 |
| Decision Date | July 27, 1990 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KHE — Reagent, Occult Blood |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.6550 |