'Rapidtec 4' Test
FDA 510(k) K041712 · American Bio Medica Corp.
510(k) numberK041712
Submission
- Device name
- 'Rapidtec 4' Test
- Applicant
- American Bio Medica Corp.
Columbia, MD, US - Received
- June 23, 2004
- Decision date
- November 3, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
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|---|---|---|---|
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| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | Assure Tech. Co., Ltd. | 06/04/2015SE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…DIS · Traditional | Healgen Scientific,, LLC | 04/24/2015SE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | Genprime, Inc. | 12/08/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
More from Phamatech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170222 | Rapid Tox Cup IILAF · Traditional | 08/15/2017SE |
| K073078 | Rapid Tox CupLAG · Traditional | 05/30/2008SE |
| K060760 | Rapidone-Buprenorphine TestDJG · Traditional | 08/07/2006SE |
| K053422 | RAPIDONE-COCAINE-150 TestDIO · Traditional | 06/15/2006SE |
| K053359 | RapidtoxDKZ · Special | 05/25/2006SE |
| K041696 | Rapid ReaderDKZ · Traditional | 07/12/2005SE |
| K030835 | 'Rapid One' - Propoxyphene TestJXN · Traditional | 05/22/2003SE |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE Dip TestDJR · Traditional | 04/30/2003SE |
| K021114 | 'Rapidtec' 5A Multiple Dip TestDKZ · Traditional | 07/23/2002SE |
| K014101 | Rapidone-Oxy TestDJG · Traditional | 03/20/2002SE |
Questions and answers
When was 'Rapidtec 4' Test cleared by the FDA?
'Rapidtec 4' Test (K041712) received a 510(k) decision of Substantially Equivalent on November 3, 2004, 133 days after the submission was received.
What is the product code of K041712?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.