Submission Details
| 510(k) Number | K872499 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 1987 |
| Decision Date | July 09, 1987 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
K872499 is an FDA 510(k) clearance for the ANATECH HEMATOXYLIN-NORMAL STRENGTH, a Hematoxylin (Class I — General Controls, product code HYJ), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on July 9, 1987, 15 days after receiving the submission on June 24, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K872499 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 1987 |
| Decision Date | July 09, 1987 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | HYJ — Hematoxylin |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.1850 |