The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Normal Angiotensin Converting Enzyme Control.
| Device ID | K940272 |
| 510k Number | K940272 |
| Device Name: | ACS 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 | Dean P Bonderman, Ph.d. |
| Correspondent | Dean P Bonderman, Ph.d. 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 | 1994-01-12 |
| Decision Date | 1994-04-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817869020298 | K940272 | 000 |
| 00817869020281 | K940272 | 000 |