Phamatech Inc.
San Diego, CA, US
PHAMATECH INC. appears in FDA device records in San Diego, CA. FDA records list 62 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 62FDA records hold 62 510(k) clearances for Phamatech Inc. between 1996 and 2018. The busiest year on record is 1999, with 16. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 1 |
| 1997 | 7 |
| 1998 | 8 |
| 1999 | 16 |
| 2000 | 3 |
| 2001 | 15 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2007 | 2 |
| 2012 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | DKZ | Substantially Equivalent | |
| K131069 | QUICKSCREEN AMPHETINE 500 TEST | DKZ | Substantially Equivalent | |
| K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST | DIO | Substantially Equivalent | |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | DIS | Substantially Equivalent | |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | DIS | Substantially Equivalent | |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | CGJ | Substantially Equivalent | |
| K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 | DJG | Substantially Equivalent | |
| K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | JXM | Substantially Equivalent | |
| K041578 | QUICKSCREEN, MODELS 9177X AND 9178X | LCM | Substantially Equivalent | |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | CGJ | Substantially Equivalent | |
| K030447 | AT HOME DRUG CUP, MODEL 9150X | MVO | Substantially Equivalent | |
| K021409 | AT HOME OVULATION TEST, MODEL 9032 | CEP | Substantially Equivalent | |
| K013412 | AT HOME DRUG TEST, MODEL 9069 | MVO | Substantially Equivalent | |
| K013410 | AT HOME DRUG TEST, MODEL 9064 | MVO | Substantially Equivalent | |
| K013409 | AT HOME DRUG TEST, MODEL 9074 | MVO | Substantially Equivalent | |
| K013408 | AT HOME DRUG TEST, MODEL 9079 | DJG | Substantially Equivalent | |
| K013407 | AT HOME DRUG TEST, MODEL 9084 | DJG | Substantially Equivalent | |
| K010836 | AT WORK DRUG TEST, MODEL 9147T AWT | LAF | Substantially Equivalent | |
| K010833 | AT WORK DRUG TEST, MODEL 9177T AWT | DIO | Substantially Equivalent | |
| K010655 | AT HOME DRUG TESTT, MODEL 9150 T | MVO | Substantially Equivalent | |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | MVO | Substantially Equivalent | |
| K010653 | AT HOME DRUG TEST, MODEL 9068 T | MVO | Substantially Equivalent | |
| K010651 | AT HOME DRUG TEST, MODEL 9133 T | LCM | Substantially Equivalent | |
| K010650 | AT HOME DRUG TEST, MODEL 9073 T | DIO | Substantially Equivalent | |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | MVO | Substantially Equivalent | |
| K010645 | AT HOME DRUG TEST, MODEL 9063 T | DKZ | Substantially Equivalent | |
| K003858 | MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 | MVO | Substantially Equivalent | |
| K001397 | QUICKSCREEN PRO DRUG CUP, MODEL 9195X | DKZ | Substantially Equivalent | |
| K000447 | QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225 | LAF | Substantially Equivalent | |
| K000131 | QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04 | LDJ | Substantially Equivalent | |
| K994237 | AT HOME DRUG TEST, MODEL 9063 | DKZ | Substantially Equivalent | |
| K994236 | AT HOME DRUG TEST, MODEL 9133 | LCM | Substantially Equivalent | |
| K994234 | AT HOME DRUG TEST, MODEL 9083 | DJG | Substantially Equivalent | |
| K994233 | AT HOME DRUG TEST, MODEL 9068 | LAF | Substantially Equivalent | |
| K994220 | AT HOME DRUG TEST, MODEL 9078 | LDJ | Substantially Equivalent | |
| K994219 | AT HOME DRUG TEST, MODEL 9073 | DIO | Substantially Equivalent | |
| K994093 | AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C | LCL | Substantially Equivalent | |
| K993141 | AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015 | LCX | Substantially Equivalent | |
| K993165 | QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178 | DJG | Substantially Equivalent | |
| K992685 | QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C | MVO | Substantially Equivalent | |
| K992217 | AT HOME DRUG TEST, MODEL 9175 | MVO | Substantially Equivalent | |
| K991824 | AT HOME DRUG TEST, MODEL 9171 | MVO | Substantially Equivalent | |
| K991641 | AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 | MVO | Substantially Equivalent | |
| K991095 | QUICKCARD HCG COMBO TEST, MODEL #9014 | JHI | Substantially Equivalent | |
| K990249 | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 | CEP | Substantially Equivalent | |
| K982938 | QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODEL 9153 | DJR | Substantially Equivalent | |
| K982621 | QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 | MVO | Substantially Equivalent | |
| K982152 | QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021, QUICK SCREEN PRO MULTI DRUG SCREENING TEST MODL 9152 | DIS | Substantially Equivalent | |
| K981687 | QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1 | JXM | Substantially Equivalent | |
| K980896 | QUICKCARD PRO HCG TEST, MODEL 9008 | JHI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2031229 | 3000719950 | PHAMATECH INC. | 15175 Innovation Dr, San Diego, CA 92128 US | 2026 | and 9 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The Counter
- DKZEnzyme Immunoassay, Amphetamine
- DISEnzyme Immunoassay, Barbiturate
- JXMEnzyme Immunoassay, Benzodiazepine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJREnzyme Immunoassay, Methadone
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DJJFluorometry, Morphine
- LAFGas Chromatography, Methamphetamine
- MVOKit, Test, Multiple, Drugs Of Abuse, Over The Counter
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- LCLRadioimmunoassay, Phencyclidine
- QKOReagent, Coronavirus Serological
- DITThin Layer Chromatography, Amphetamine
- DMNThin Layer Chromatography, Cocaine
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain