K900028 is an FDA 510(k) clearance for the ALLERCOAT MICROPLATE SYSTEM. This device is classified as a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I - General Controls, product code JJQ).
Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on January 22, 1990, 19 days after receiving the submission on January 3, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.2300.
| 510(k) Number | K900028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 03, 1990 |
| Decision Date | January 22, 1990 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2300 |