Submission Details
| 510(k) Number | K821019 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 12, 1982 |
| Decision Date | April 26, 1982 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
K821019 is an FDA 510(k) clearance for the PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU, a Mounting Media (Class I — General Controls, product code LEB), submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on April 26, 1982, 14 days after receiving the submission on April 12, 1982. This device falls under the Pathology review panel. Regulated under 21 CFR 864.4010.
| 510(k) Number | K821019 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 12, 1982 |
| Decision Date | April 26, 1982 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Pathology (PA) |
| Summary | — |
| Product Code | LEB — Mounting Media |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 864.4010 |