The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Angiotensin Converting Enzyme (ace) Calibrator.
| Device ID | K930477 |
| 510k Number | K930477 |
| Device Name: | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR |
| Classification | Calibrator, Primary |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Contact | Roy Speck |
| Correspondent | Roy Speck ANALYTICAL CONTROL SYSTEMS, INC. 155 E. MARKET, SUITE 502 Indianapolis, IN 46204 |
| Product Code | JIS |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-29 |
| Decision Date | 1993-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516741545 | K930477 | 000 |
| 00817869020304 | K930477 | 000 |