The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Hcg Stat Calcheck 5.
| Device ID | K093700 |
| 510k Number | K093700 |
| Device Name: | ELECSYS HCG STAT CALCHECK 5 |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Contact | Kelly C O'maine Adams |
| Correspondent | Kelly C O'maine Adams ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50410 Indianapolis, IN 46250 -0416 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-01 |
| Decision Date | 2010-03-04 |
| Summary: | summary |