K891929 is an FDA 510(k) clearance for the MONI-TROL(R). This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).
Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on May 9, 1989, 42 days after receiving the submission on March 28, 1989.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K891929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1989 |
| Decision Date | May 09, 1989 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JJY — Multi-analyte Controls, All Kinds (assayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |