The following data is part of a premarket notification filed by Roche with the FDA for Homocysteine Test.
| Device ID | K113793 |
| 510k Number | K113793 |
| Device Name: | HOMOCYSTEINE TEST |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | ROCHE 9115 HAGUE RD P.O. BOX 50416 Indianapolis, IN 46250 |
| Contact | Susan Hollandbeck |
| Correspondent | Susan Hollandbeck ROCHE 9115 HAGUE RD P.O. BOX 50416 Indianapolis, IN 46250 |
| Product Code | LPS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJT |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336121290 | K113793 | 000 |
| 04015630933631 | K113793 | 000 |
| 04015630929979 | K113793 | 000 |
| 04015630927326 | K113793 | 000 |