The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Cyclic Amp Radioimmunoassay Kit [125i].
| Device ID | K811273 |
| 510k Number | K811273 |
| Device Name: | CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] |
| Classification | Radioimmunoassay, Cyclic Amp |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CHO |
| CFR Regulation Number | 862.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-07 |
| Decision Date | 1981-05-27 |