The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Reagent A And Reagent B.
| Device ID | K874413 |
| 510k Number | K874413 |
| Device Name: | REAGENT A AND REAGENT B |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Contact | J Sullivan |
| Correspondent | J Sullivan SERADYN, INC. P.O. BOX 1210 Indianapolis, IN 46206 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1988-01-05 |