The following data is part of a premarket notification filed by Laboratory Diagnostics Co., Inc. with the FDA for Quick Cept.
| Device ID | K801668 |
| 510k Number | K801668 |
| Device Name: | QUICK CEPT |
| Classification | Differential Rate Kinetic Method, Cpk Or Isoenzymes |
| Applicant | LABORATORY DIAGNOSTICS CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHS |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-21 |
| Decision Date | 1980-08-13 |