Submission Details
| 510(k) Number | K131128 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2013 |
| Decision Date | November 13, 2013 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
Nov 2013
Decision
204d
Days
Class 2
Risk
About This 510(k) Submission
K131128 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Omega Laboratories, Inc. (Mogadore, US). The FDA issued a Cleared decision on November 13, 2013, 204 days after receiving the submission on April 23, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.
Device Classification
| Product Code | DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3250 |
Manufacturer
Similar Devices — DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
All 144
K213211 · Carolina Liquid Chemistries Corp.
· Jan 2022
K211973 · Microgenics Corporation
· Sep 2021
K191638 · Medtest DX
· Mar 2020
K181499 · Microgenics Corporation
· Jul 2018
K170293 · Siemens Healthcare Diagnostics, Inc.
· Oct 2017
K163570 · Carolina Liquid Chemistries Corporation
· Aug 2017
More from Omega Laboratories, Inc.
View all
K142855
· DKZ · Jul 2015
K140671
· DJG · Jan 2015
K131181
· LCM · Jun 2013
K122759
· LDJ · Dec 2012
K112808
· DIO · Jan 2012