The following data is part of a premarket notification filed by Smith Kline Diagnostics, Inc. with the FDA for Target Isocheck Control Serum.
| Device ID | K821183 |
| 510k Number | K821183 |
| Device Name: | TARGET ISOCHECK CONTROL SERUM |
| Classification | Enzyme Controls (assayed And Unassayed) |
| Applicant | SMITH KLINE DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJT |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-27 |
| Decision Date | 1982-05-14 |