The following data is part of a premarket notification filed by E. R. Squibb & Sons, Inc. with the FDA for Ria Stat 16.
| Device ID | K821494 |
| 510k Number | K821494 |
| Device Name: | RIA STAT 16 |
| Classification | Counter (beta, Gamma) For Clinical Use |
| Applicant | E. R. SQUIBB & SONS, INC. 40 W 57TH ST. New York, NY 10019 |
| Product Code | JJJ |
| CFR Regulation Number | 862.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-18 |
| Decision Date | 1982-06-03 |