The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys B-crosslaps Calcheck.
| Device ID | K000042 |
| 510k Number | K000042 |
| Device Name: | ELECSYS B-CROSSLAPS CALCHECK |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Contact | Kay A Laps |
| Correspondent | Kay A Laps ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50416 Indianapolis, IN 46250 -0457 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-06 |
| Decision Date | 2000-03-17 |