K820923 is an FDA 510(k) clearance for the DULBECCO'S PBS POWDER. This device is classified as a Formulations, Balanced Salt Solutions (Class I - General Controls, product code KIP).
Submitted by Dutchland Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982, 20 days after receiving the submission on April 1, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 864.2875.
| 510(k) Number | K820923 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 1982 |
| Decision Date | April 21, 1982 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | KIP — Formulations, Balanced Salt Solutions |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2875 |