Submission Details
| 510(k) Number | K841431 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 1984 |
| Decision Date | July 06, 1984 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
K841431 is an FDA 510(k) clearance for the RADIOGRAPHIC FILM PROCESSOR M-30CR &, a Processor, Cine Film (Class II — Special Controls, product code IXX), submitted by The Allen Products Co. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984, 91 days after receiving the submission on April 6, 1984. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K841431 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 1984 |
| Decision Date | July 06, 1984 |
| Days to Decision | 91 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 |