K994200 is an FDA 510(k) clearance for the ACCESS HYBRITECH PSA QC, MODEL 37209. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 18, 2000, 36 days after receiving the submission on December 13, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K994200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1999 |
| Decision Date | January 18, 2000 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |