Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, Collector
FDA 510(k) K132096 · Biophor Diagnostics, Inc.
510(k) numberK132096
Submission
- Device name
- Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, Collector
- Applicant
- Biophor Diagnostics, Inc.
Redwood City, CA, US - Received
- July 8, 2013
- Decision date
- October 18, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K133642 | Rapidfret Oral Fluid Assay for Opiates; Rapidfret Oral Fluid Calibrators, Controls…DJG · Traditional | 01/24/2014SE |
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Questions and answers
When was Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, Collector cleared by the FDA?
Rapidfret Oral Fluid Assay for THC, THC Calibrator Set, THC Control Set, Collector (K132096) received a 510(k) decision of Substantially Equivalent on October 18, 2013, 102 days after the submission was received.
What is the product code of K132096?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.