The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys N-mid Osteocalcin, Elecsys Osteocalcin Calset, Elecsys Osteocalcin Calcheck.
Device ID | K051297 |
510k Number | K051297 |
Device Name: | ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK |
Classification | System, Test, Osteocalcin |
Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Contact | Kay A Taylor |
Correspondent | Kay A Taylor ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
Product Code | NEO |
Subsequent Product Code | JIT |
Subsequent Product Code | JJX |
CFR Regulation Number | 862.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-05-18 |
Decision Date | 2005-09-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04015630940462 | K051297 | 000 |
04015630939084 | K051297 | 000 |