The following data is part of a premarket notification filed by Catch, Inc. with the FDA for Homogeneous Enzymic Homocysteine Reagent.
| Device ID | K011689 |
| 510k Number | K011689 |
| Device Name: | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | CATCH, INC. PO BOX 2219 Longview, WA 98632 |
| Contact | Mark E Legaz |
| Correspondent | Mark E Legaz CATCH, INC. PO BOX 2219 Longview, WA 98632 |
| Product Code | LPS |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-31 |
| Decision Date | 2001-07-25 |