Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid Collector
FDA 510(k) K122703 · Biophor Diagnostics, Inc.
510(k) numberK122703
Submission
- Device name
- Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid Collector
- Applicant
- Biophor Diagnostics, Inc.
Redwood City, CA, US - Received
- September 4, 2012
- Decision date
- April 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCM – Enzyme Immunoassay, Phencyclidine
- Device class
- Unclassified
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| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsLCM · Traditional | Immunalysis Corporation | 09/04/2015SE |
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| K131181 | Omega Laboratories Hair Drug Screening Assay PhencyclidineLCM · Traditional | Omega Laboratories, Inc. | 06/25/2013SE |
| K111928 | Psychemedics Phencyclidine EiaLCM · Traditional | Psychemedics Corp. | 05/01/2012SE |
| K101746 | Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayLCM · Traditional | Microgenics Corp. | 04/08/2011SE |
| K093989 | Oral Fluid PhencyclidineLCM · Traditional | Roche Diagnostics | 01/25/2011SE |
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Questions and answers
When was Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid Collector cleared by the FDA?
Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease Oral Fluid Collector (K122703) received a 510(k) decision of Substantially Equivalent on April 25, 2013, 233 days after the submission was received.
What is the product code of K122703?
The FDA product code is LCM – Enzyme Immunoassay, Phencyclidine, a Unclassified device.