K770548 is an FDA 510(k) clearance for the IMMUNOPLATE III RADIO IMMUNODIFFUSION. This device is classified as a Plates And Equipment, Radial Immunodiffusion (Class I - General Controls, product code JZQ).
Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on April 15, 1977, 25 days after receiving the submission on March 21, 1977.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4800.
| 510(k) Number | K770548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1977 |
| Decision Date | April 15, 1977 |
| Days to Decision | 25 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZQ — Plates And Equipment, Radial Immunodiffusion |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.4800 |