K820918 is an FDA 510(k) clearance for the HMEM POWDERED MEDIUM. This device is classified as a Media And Components, Synthetic Cell And Tissue Culture (Class I - General Controls, product code KIT).
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 864.2220.
| 510(k) Number | K820918 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 | KIT — Media And Components, Synthetic Cell And Tissue Culture |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.2220 |