510(k) K011689 ยท LPS Urinary Homocystine (Nonquantitative) Test System
HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
| Applicant | Catch, Inc., Longview WA, US |
| Decision | Substantially Equivalent, Jul 25, 2001 |
| Received | May 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011689
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2009 | Catch Incorporated Homocysteine Reagent Test Kit. The Homocysteine test kits were manufactured under 2 brand names. The first brand name Catch, the label reads "CATCH Catch Inc., Bothell, WA 98011 HOMOCYSTEINE REAGEN Terminated |
LPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.