Accusign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp, Biosign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp
FDA 510(k) K991076 · Princeton BioMeditech Corp.
510(k) numberK991076
Submission
- Device name
- Accusign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp, Biosign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- March 26, 1999
- Decision date
- April 15, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code DIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | Immunalysis Corporation | 10/14/2016SE |
| 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 |
|---|---|---|
| K251538 | Status COVID-19/Flu A&BSCA · Dual Track | 11/14/2025SE |
| K182157 | BioSign Flu A+BPSZ · Special | 09/18/2018SE |
| K130650 | Status DS OxyDJG · Traditional | 02/26/2014SE |
| K133474 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 12/10/2013SE |
| K132465 | Biosign Flu a + B, Status Flu a & BPSZ · Special | 09/09/2013SE |
| K083746 | Biosign Flu A+BPSZ · Traditional | 11/10/2010SE |
| K100817 | Biosign Ifobtest, Biosign Fecal Occult Blood TestKHE · Traditional | 07/01/2010SE |
| K100341 | Spermcheck FertilityPOV · Traditional | 05/04/2010SE |
| K082661 | Biostrep a, Biosign Strep a, Statusfirst Strep aGTY · Special | 10/06/2008SE |
| K073039 | Spermcheck VasectomyPOV · Traditional | 01/24/2008SE |
Questions and answers
When was Accusign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp, Biosign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp cleared by the FDA?
Accusign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp, Biosign DOA3, DOA3(BZO/BAR/PCP), Bzo/Bar/Pcp (K991076) received a 510(k) decision of Substantially Equivalent on April 15, 1999, 20 days after the submission was received.
What is the product code of K991076?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.