K831448 is an FDA 510(k) clearance for the SPIA SYS FOR SOLID PHASE IMMUNOASSAYS. This device is classified as a Device, General Purpose, Microbiology, Diagnostic (Class I - General Controls, product code LIB).
Submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983, 34 days after receiving the submission on May 5, 1983.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K831448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 1983 |
| Decision Date | June 08, 1983 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LIB — Device, General Purpose, Microbiology, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |