The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Serum B-crosslaps/serum Immunoassay.
| Device ID | K993706 |
| 510k Number | K993706 |
| Device Name: | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY |
| Classification | Column Chromatography & Color Development, Hydroxyproline |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Priscilla A Hamill |
| Correspondent | Priscilla A Hamill ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JMM |
| CFR Regulation Number | 862.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-02 |
| Decision Date | 2000-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630938902 | K993706 | 000 |