The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Ck/ld Isoenzyme Control Prod. #acs Ct101.
| Device ID | K800370 |
| 510k Number | K800370 |
| Device Name: | CK/LD ISOENZYME CONTROL PROD. #ACS CT101 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-02-20 |
| Decision Date | 1980-03-12 |