Submission Details
| 510(k) Number | K870852 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 1987 |
| Decision Date | March 31, 1987 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
K870852 is an FDA 510(k) clearance for the NBF 10% NEUTRAL BUFFERED FORMALIN, a Formalin, Neutral Buffered (Class I — General Controls, product code IFP), submitted by Anatech, Ltd. (Battle Creek, US). The FDA issued a Cleared decision on March 31, 1987, 28 days after receiving the submission on March 3, 1987. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K870852 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 03, 1987 |
| Decision Date | March 31, 1987 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | IFP — Formalin, Neutral Buffered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.4010 |