Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set
FDA 510(k) K141748 · Biophor Diagnostics, Inc.
510(k) numberK141748
Submission
- Device name
- Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set
- Applicant
- Biophor Diagnostics, Inc.
Redwood City, CA, US - Received
- June 30, 2014
- Decision date
- May 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
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|---|---|---|
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine…LAF · Traditional | 09/18/2015SE |
| K142129 | Rapidfret Oral Fluid Assay for Cocaine, Rapidfret Oral Fluid Cocaine Calibrator Set…DIO · Traditional | 07/24/2015SE |
| K133047 | Rapidfret Oral Fluid Assay for Mdma, Rapidfret Oral Fluid Calibrators, Rapidfret Oral…LAF · Traditional | 12/18/2014SE |
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| K132096 | Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, CollectorLDJ · Traditional | 10/18/2013SE |
| K122703 | Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…LCM · Traditional | 04/25/2013SE |
Questions and answers
When was Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set cleared by the FDA?
Rapidfret Oral Fluid Assay for Amphetamine, Rapidfret Oral Fluid Amphetamine Calibrator Set, Rapidfret Oral Fluid Amphetamine Control Set (K141748) received a 510(k) decision of Substantially Equivalent on May 20, 2015, 324 days after the submission was received.
What is the product code of K141748?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.