The following data is part of a premarket notification filed by Catch Incorporated with the FDA for Liquid Stable (ls) 2-part Homocysteine Reagent.
| Device ID | K062808 |
| 510k Number | K062808 |
| Device Name: | LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | CATCH INCORPORATED 21031 SE 202ND STREET Renton, WA 98058 |
| Contact | Cindy Green |
| Correspondent | Cindy Green CATCH INCORPORATED 21031 SE 202ND STREET Renton, WA 98058 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-19 |
| Decision Date | 2006-10-13 |
| Summary: | summary |