The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Normal Angiotensin Converting Enzyme Control.
| Device ID | K925906 |
| 510k Number | K925906 |
| Device Name: | NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Contact | Roy Speck |
| Correspondent | Roy Speck ANALYTICAL CONTROL SYSTEMS, INC. 9058 TECHNOLOGY DR. Fishers, IN 46038 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-20 |
| Decision Date | 1993-02-18 |