510(k) K142293
- Device
- Rapidfret Oral Fluid Assay For Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
- Applicant
- BIOPHOR DIAGNOSTICS, INC.
- 510(k) number
- K142293
- Product code
- LAF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-18
- Date received
- 2014-08-18
- Regulation
- 862.3610
- Classification name
- Gas Chromatography, Methamphetamine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nathaniel G. Butlin
- Address
- 1201 Douglas Ave. Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3043127647
- 3008416529
- 3007606081
- 3010939897
- 3031697086
- 3009238284
- 2517506
- 2030861
- 3007838093
- 3023296261
- 3027519599
- 3004987297
- 3005333358
- 2025099
- 3006198300
- 3012725363
- 3002806944
- 3030413233
- 1649661
- 3004847291
- 3008987086
- 3006361161
- 2060833
- 2027969
- 3030648160
- 2031229
- 3023322455
- 3013684380
- 3013982035
- 3010852191
- 3005345870
- 8043323
- 3009526336
- 9610126
- 2020952
- 2029372
- 3009585529
- 1036362
- 2000007960
- 3021186226
- 3008517993
- 3012073813
- 3005360469
- 3016609999
- 1832216
- 3010220539
- 2087033
- 3013679502
- 1827821
- 3024463179
- 3004635103
- 3005984081
- 2246703
- 1910144
- 2915274
- 3006048451
- 3003917514
- 3034694973
- 2032364
- 3003610499
- 3009212837
- 3005641941
- 2030633
- 3008852306
Source Documents#
Other 510(k) Records For Product Code LAF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203647 | SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021-12-22 |
| K210212 | Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair | Psychemedics Corporation | 2021-12-15 |
| K201442 | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers | Diatron Group | 2020-07-31 |
| K170222 | Rapid Tox Cup II | American Bio Medica Corp. | 2017-08-15 |
| K153693 | Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | 2016-03-18 |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) | Healgen Scientific,, LLC | 2015-03-04 |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | W.H.P.M., Inc. | 2015-02-26 |
| K133047 | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU | Biophor Diagnostics, Inc. | 2014-12-18 |
| K131652 | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS | Lin-Zhi International, Inc. | 2014-03-21 |
| K111927 | PSYCHEMEDICS METHAMPHETAMINE EIA | Psychemedics Corp. | 2012-05-01 |
| K113661 | LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLS | Lin-Zhi International, Inc. | 2012-01-23 |
| K112236 | WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST | Guangzhou Wondfo Biotech Co., Ltd. | 2011-09-19 |
| K101973 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA) | Omega Laboratories, Inc. | 2011-08-16 |
| K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY | Microgenics Corp. | 2011-04-08 |
| K093884 | ROCHE FLUDI METHAMPHETAMINE | Roche Diagnostics | 2011-02-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary