Company ยท US
Phamatech
FDA 510(k) clearances and medical device recalls filed under this name, 1996 to 2018. Name variants (Inc, Corp, punctuation) are merged.
62510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MVO | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter | 14 |
| DJG | Enzyme Immunoassay, Opiates | 6 |
| DKZ | Enzyme Immunoassay, Amphetamine | 6 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 5 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 |
| LAF | Gas Chromatography, Methamphetamine | 4 |
| LCM | Enzyme Immunoassay, Phencyclidine | 4 |
| DIS | Enzyme Immunoassay, Barbiturate | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 2 |
| DIT | Thin Layer Chromatography, Amphetamine | 1 |
| DJR | Enzyme Immunoassay, Methadone | 1 |
| DMN | Thin Layer Chromatography, Cocaine | 1 |
| LCL | Radioimmunoassay, Phencyclidine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2018 | K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z Phamatech, Inc. | DKZ |
| May 14, 2014 | K131069 | QUICKSCREEN AMPHETINE 500 TEST Phamatech, Inc. | DKZ |
| Feb 1, 2012 | K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST Phamatech, Inc. | DIO |
| Dec 7, 2007 | K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC Phamatech, Inc. | DIS |
| Dec 7, 2007 | K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X Phamatech, Inc. | DIS |
| Feb 25, 2005 | K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 Phamatech, Inc. | CGJ |
| Feb 7, 2005 | K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 Phamatech, Inc. | DJG |
| Dec 29, 2004 | K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X Phamatech, Inc. | JXM |
| Sep 10, 2004 | K041578 | QUICKSCREEN, MODELS 9177X AND 9178X Phamatech | LCM |
| May 20, 2004 | K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 Phamatech, Inc. | CGJ |
| Apr 14, 2003 | K030447 | AT HOME DRUG CUP, MODEL 9150X Phamatech | MVO |
| May 24, 2002 | K021409 | AT HOME OVULATION TEST, MODEL 9032 Phamatech, Inc. | CEP |
| Dec 6, 2001 | K013412 | AT HOME DRUG TEST, MODEL 9069 Phamatech, Inc. | MVO |
| Dec 6, 2001 | K013410 | AT HOME DRUG TEST, MODEL 9064 Phamatech, Inc. | MVO |
| Dec 6, 2001 | K013409 | AT HOME DRUG TEST, MODEL 9074 Phamatech, Inc. | MVO |
| Dec 6, 2001 | K013408 | AT HOME DRUG TEST, MODEL 9079 Phamatech, Inc. | DJG |
| Dec 6, 2001 | K013407 | AT HOME DRUG TEST, MODEL 9084 Phamatech, Inc. | DJG |
| Apr 11, 2001 | K010836 | AT WORK DRUG TEST, MODEL 9147T AWT Phamatech | LAF |
| Apr 11, 2001 | K010833 | AT WORK DRUG TEST, MODEL 9177T AWT Phamatech | DIO |
| Apr 5, 2001 | K010655 | AT HOME DRUG TESTT, MODEL 9150 T Phamatech | MVO |
| Apr 5, 2001 | K010654 | AT HOME DRUG TEST, MODEL 9078 T Phamatech | MVO |
| Apr 5, 2001 | K010653 | AT HOME DRUG TEST, MODEL 9068 T Phamatech | MVO |
| Mar 30, 2001 | K010651 | AT HOME DRUG TEST, MODEL 9133 T Phamatech | LCM |
| Mar 30, 2001 | K010650 | AT HOME DRUG TEST, MODEL 9073 T Phamatech | DIO |
| Mar 30, 2001 | K010646 | AT HOME DRUG TEST, MODEL 9083 T Phamatech | MVO |
| Mar 30, 2001 | K010645 | AT HOME DRUG TEST, MODEL 9063 T Phamatech | DKZ |
| Feb 12, 2001 | K003858 | MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 Phamatech | MVO |
| May 26, 2000 | K001397 | QUICKSCREEN PRO DRUG CUP, MODEL 9195X Phamatech | DKZ |
| Mar 7, 2000 | K000447 | QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 Phamatech | LAF |
| Feb 4, 2000 | K000131 | QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 Phamatech | LDJ |
| Dec 30, 1999 | K994237 | AT HOME DRUG TEST, MODEL 9063 Phamatech | DKZ |
| Dec 30, 1999 | K994236 | AT HOME DRUG TEST, MODEL 9133 Phamatech | LCM |
| Dec 30, 1999 | K994234 | AT HOME DRUG TEST, MODEL 9083 Phamatech | DJG |
| Dec 30, 1999 | K994233 | AT HOME DRUG TEST, MODEL 9068 Phamatech | LAF |
| Dec 30, 1999 | K994220 | AT HOME DRUG TEST, MODEL 9078 Phamatech | LDJ |
| Dec 30, 1999 | K994219 | AT HOME DRUG TEST, MODEL 9073 Phamatech | DIO |
| Dec 16, 1999 | K994093 | AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C Phamatech | LCL |
| Nov 8, 1999 | K993141 | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 Phamatech | LCX |
| Oct 20, 1999 | K993165 | QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 Phamatech | DJG |
| Oct 6, 1999 | K992685 | QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C Phamatech | MVO |
| Jul 13, 1999 | K992217 | AT HOME DRUG TEST, MODEL 9175 Phamatech | MVO |
| Jun 11, 1999 | K991824 | AT HOME DRUG TEST, MODEL 9171 Phamatech | MVO |
| Jun 1, 1999 | K991641 | AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 Phamatech | MVO |
| Apr 28, 1999 | K991095 | QUICKCARD HCG COMBO TEST, MODEL #9014 Phamatech | JHI |
| Mar 22, 1999 | K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 Phamatech | CEP |
| Feb 5, 1999 | K982938 | QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 Phamatech | DJR |
| Oct 16, 1998 | K982621 | QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 Phamatech | MVO |
| Sep 21, 1998 | K982152 | QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 Phamatech | DIS |
| Jun 3, 1998 | K981687 | QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 Phamatech | JXM |
| Apr 2, 1998 | K980896 | QUICKCARD PRO HCG TEST, MODEL 9008 Phamatech | JHI |
Newest 50 of 62.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||