The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Homocysteine And Controls.
| Device ID | K061598 |
| 510k Number | K061598 |
| Device Name: | HEMOSIL HOMOCYSTEINE AND CONTROLS |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950453031 | K061598 | 000 |
| 08426950453024 | K061598 | 000 |