K982022 is an FDA 510(k) clearance for the VIGIL HEMOGLOBIN (HBALC) CONTROLS. 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. (Brea, US). The FDA issued a Cleared decision on July 6, 1998, 27 days after receiving the submission on June 9, 1998.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K982022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 09, 1998 |
| Decision Date | July 06, 1998 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| 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 |