The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Calcheck Psa.
| Device ID | K970458 |
| 510k Number | K970458 |
| Device Name: | ELECSYS CALCHECK PSA |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Patricia M Klimley |
| Correspondent | Patricia M Klimley BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-06 |
| Decision Date | 1997-03-06 |
| Summary: | summary |