K850421 is an FDA 510(k) clearance for the CINE RADIOGRAPHIC FILM PROCESSOR M-45CR. This device is classified as a Processor, Cine Film (Class II - Special Controls, product code IXX).
Submitted by The Allen Products Co. (Milford, US). The FDA issued a Cleared decision on March 22, 1985, 46 days after receiving the submission on February 4, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K850421 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1985 |
| Decision Date | March 22, 1985 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IXX — Processor, Cine Film |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |