K892213 is an FDA 510(k) clearance for the ACS COLLOID OSMOTIC PRESSURE CALIBRATOR. This device is classified as a Calibrator, Surrogate (Class II - Special Controls, product code JIW).
Submitted by Analytical Control Systems, Inc. (Fishers, US). The FDA issued a Cleared decision on June 21, 1989, 79 days after receiving the submission on April 3, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.
| 510(k) Number | K892213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1989 |
| Decision Date | June 21, 1989 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JIW — Calibrator, Surrogate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1150 |