K855034 is an FDA 510(k) clearance for the AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT. This device is classified as a Peroxidase Anti-peroxidase Immunohistochemical Stain (Class I - General Controls, product code LIJ).
Submitted by Bartels Immunodiagnostic Supplies, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 11, 1986, 84 days after receiving the submission on December 17, 1985.
This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4400.
| 510(k) Number | K855034 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1985 |
| Decision Date | March 11, 1986 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | LIJ — Peroxidase Anti-peroxidase Immunohistochemical Stain |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.4400 |