K970458 is an FDA 510(k) clearance for the ELECSYS CALCHECK PSA. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).
Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on March 6, 1997, 28 days after receiving the submission on February 6, 1997.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K970458 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1997 |
| Decision Date | March 06, 1997 |
| Days to Decision | 28 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 |