K981914 is an FDA 510(k) clearance for the TURBIDIMETRIC/NEPHELOMETRIC HUMAN SERUM REFERENCE PREPARATION. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on November 26, 1999, 543 days after receiving the submission on June 1, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K981914 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1998 |
| Decision Date | November 26, 1999 |
| Days to Decision | 543 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |