The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Iron Standard.
| Device ID | K052002 |
| 510k Number | K052002 |
| Device Name: | IRON STANDARD |
| Classification | Calibrator, Secondary |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Contact | Corina Harper |
| Correspondent | Corina Harper ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-25 |
| Decision Date | 2005-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630996902 | K052002 | 000 |