Accusign Met/Biosign Met
FDA 510(k) K961249 · Princeton BioMeditech Corp.
510(k) numberK961249
Submission
- Device name
- Accusign Met/Biosign Met
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- April 1, 1996
- Decision date
- April 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LAF – Gas Chromatography, Methamphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3610
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayLAF · Traditional | Immunalysis Corporation | 12/22/2021SE |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairLAF · Traditional | Psychemedics Corporation | 12/15/2021SE |
| K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersLAF · Traditional | Diatron Group | 07/31/2020SE |
| K170222 | Rapid Tox Cup IILAF · Traditional | American Bio Medica Corp. | 08/15/2017SE |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLAF · Traditional | Immunalysis Corporation | 03/18/2016SE |
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…LAF · Traditional | Biophor Diagnostics, Inc. | 09/18/2015SE |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test…LAF · Traditional | Healgen Scientific,, LLC | 03/04/2015SE |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF · Traditional | W.H.P.M., Inc. | 02/26/2015SE |
| K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…LAF · Traditional | Biophor Diagnostics, Inc. | 12/18/2014SE |
| K131652 | Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, ControlsLAF · Traditional | Lin-Zhi International, Inc. | 03/21/2014SE |
More from Lin-Zhi International, Inc.
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| 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 Met/Biosign Met cleared by the FDA?
Accusign Met/Biosign Met (K961249) received a 510(k) decision of Substantially Equivalent on April 25, 1996, 24 days after the submission was received.
What is the product code of K961249?
The FDA product code is LAF – Gas Chromatography, Methamphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3610.