Submission Details
| 510(k) Number | K121053 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 06, 2012 |
| Decision Date | July 31, 2012 |
| Days to Decision | 116 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Traditional
DIAZYME HOMOCYSTEINE POC TEST KIT
Jul 2012
Decision
116d
Days
Class 2
Risk
About This 510(k) Submission
K121053 is an FDA 510(k) clearance for the DIAZYME HOMOCYSTEINE POC TEST KIT, a Urinary Homocystine (nonquantitative) Test System (Class II — Special Controls, product code LPS), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on July 31, 2012, 116 days after receiving the submission on April 6, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1377.
Device Classification
| Product Code | LPS — Urinary Homocystine (nonquantitative) Test System |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1377 |
Manufacturer
Similar Devices — LPS Urinary Homocystine (nonquantitative) Test System
All 28
K123930 · Ortho-Clinical Diagnostics, Inc.
· May 2013
K121533 · Tosoh Bioscience, Inc.
· Jun 2012
K113793 · Roche
· Jun 2012
K112790 · Axis-Shield Diagnostics, Ltd.
· May 2012
K083222 · Axis-Shield Diagnostics, Ltd.
· Jul 2009
K080851 · Anticancer, Inc.
· Oct 2008
More from Diazyme Laboratories
View all
K172992
· MRG · Jan 2018
K163418
· DHA · Aug 2017
K162297
· PTF · Apr 2017
K160762
· LCP · Nov 2016
K153394
· DFH · Nov 2016