The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Spin Chem Reagents & Standards.
| Device ID | K821184 |
| 510k Number | K821184 |
| Device Name: | SPIN CHEM REAGENTS & STANDARDS |
| Classification | Photometric Method, Iron (non-heme) |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JIY |
| CFR Regulation Number | 862.1410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-24 |