RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
FDA 510(k) clearance K133047 · decided 2014-12-18
Clearance details
- K-number
- K133047
- Device name
- RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
- Applicant
- Biophor Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-09-27
- Decision date
- 2014-12-18
- Days to decision
- 447 days
- Clearance type
- Traditional
- Product code
- LAF
- Device class
- 2
- Regulation number
- 862.3610
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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| Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (K150096) | Healgen Scientific,, LLC | 2015-03-04 |
| First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (K150162) | W.H.P.M., Inc. | 2015-02-26 |
| LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS (K131652) | Lin-Zhi International, Inc. | 2014-03-21 |
| PSYCHEMEDICS METHAMPHETAMINE EIA (K111927) | Psychemedics Corp. | 2012-05-01 |
| LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS (K113661) | Lin-Zhi International, Inc. | 2012-01-23 |
| WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST (K112236) | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-19 |
Recalls involving this device
No recalls on record reference this clearance.