510(k) K122703
- Device
- RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR
- Applicant
- BIOPHOR DIAGNOSTICS, INC.
- 510(k) number
- K122703
- Product code
- LCM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-04-25
- Date received
- 2012-09-04
- Regulation
- 510(k) Premarket Notification
- Classification name
- Enzyme Immunoassay, Phencyclidine
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Toxicology
- Device class
- U
- 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#
- 3015821396
- 3010934853
- 3008741972
- 3009238284
- 3031697086
- 2030861
- 3006198300
- 3030413233
- 2060833
- 3030648160
- 3010825766
- 2020952
- 3009585529
- 3010800486
- 3013679502
- 2246703
- 1910144
- 3006048451
- 3003917514
- 3009212837
- 2050010
- 3005641941
- 2030633
- 3011522054
- 3005174594
- 3007606081
- 3004987297
- 3004175381
- 3012725363
- 1649661
- 3000308930
- 3008987086
- 2027969
- 3013223546
- 2031229
- 3013684380
- 3010852191
- 1220972
- 2029372
- 3003795116
- 3036649420
- 3021186226
- 1832216
- 3010220539
- 3034694973
- 3003610499
- 2432235
- 3010939897
- 3016610313
- 3027519599
- 3005333358
- 3004493545
- 3011559327
- 3002642396
- 8043323
- 3008517993
- 3012073813
- 3005360469
- 3005755244
- 3012963943
- 2250051
- 3004635103
- 3038614708
- 2050012
- 2915274
- 3025041446
- 9610529
- 3014607865
- 3043127647
- 3008416529
- 3014223276
- 2517506
- 3007838093
- 3023296261
- 2025099
- 1319808
- 3004847291
- 3023322455
- 3005345870
- 9610126
Source Documents#
Other 510(k) Records For Product Code LCM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K212952 | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | Psychemedics Corporation | 2022-04-18 |
| K203489 | SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2021-04-20 |
| K181135 | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | 2019-01-24 |
| K163220 | Atellica CH Phencyclidine (Pcp) | Siemens Healthcare Diagnostics, Inc. | 2017-04-06 |
| K152176 | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | 2015-09-04 |
| K142044 | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | Guangzhou Wondfo Biotech Co., Ltd. | 2014-08-25 |
| K131181 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY PHENCYCLIDINE | Omega Laboratories, Inc. | 2013-06-25 |
| K111928 | PSYCHEMEDICS PHENCYCLIDINE EIA | Psychemedics Corp. | 2012-05-01 |
| K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | Microgenics Corp. | 2011-04-08 |
| K093989 | ORAL FLUID PHENCYCLIDINE | Roche Diagnostics | 2011-01-25 |
| K101059 | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE | Omega Laboratories, Inc. | 2010-07-12 |
| K080431 | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 | Quantrx Biomedical Corporation | 2009-01-08 |
| K062094 | VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V | Ortho-Clinical Diagnostics, Inc. | 2006-11-22 |
| K060353 | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | Acro Biotech, LLC | 2006-05-03 |
| K042726 | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP | Quest Diagnostics, Inc. | 2005-07-28 |
Legacy Summary#
summary
FDA Review#
Decision Summary