The following data is part of a premarket notification filed by Analytical Control Systems, Inc. with the FDA for Acs Colloid Osmotic Pressure Calibrator.
| Device ID | K892213 |
| 510k Number | K892213 |
| Device Name: | ACS COLLOID OSMOTIC PRESSURE CALIBRATOR |
| Classification | Calibrator, Surrogate |
| Applicant | ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers, IN 46060 |
| Contact | Pauline W Bonderman |
| Correspondent | Pauline W Bonderman ANALYTICAL CONTROL SYSTEMS, INC. 9001 TECHNOLOGY DR. SUITE A Fishers, IN 46060 |
| Product Code | JIW |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-03 |
| Decision Date | 1989-06-21 |