Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Phamatech — Predicate Candidate Screening

47 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

27 daysmedian FDA review time

62 days90th percentile

47clearances measured

K-number	Device	Applicant	Decided	Review days
K041578	QUICKSCREEN, MODELS 9177X AND 9178X	Phamatech	2004-09-10	88
K030447	AT HOME DRUG CUP, MODEL 9150X	Phamatech	2003-04-14	62
K010836	AT WORK DRUG TEST, MODEL 9147T AWT	Phamatech	2001-04-11	22
K010833	AT WORK DRUG TEST, MODEL 9177T AWT	Phamatech	2001-04-11	22
K010655	AT HOME DRUG TESTT, MODEL 9150 T	Phamatech	2001-04-05	31
K010654	AT HOME DRUG TEST, MODEL 9078 T	Phamatech	2001-04-05	31
K010653	AT HOME DRUG TEST, MODEL 9068 T	Phamatech	2001-04-05	31
K010646	AT HOME DRUG TEST, MODEL 9083 T	Phamatech	2001-03-30	25
K010650	AT HOME DRUG TEST, MODEL 9073 T	Phamatech	2001-03-30	25
K010651	AT HOME DRUG TEST, MODEL 9133 T	Phamatech	2001-03-30	25
K010645	AT HOME DRUG TEST, MODEL 9063 T	Phamatech	2001-03-30	25
K003858	MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 91	Phamatech	2001-02-12	61
K001397	QUICKSCREEN PRO DRUG CUP, MODEL 9195X	Phamatech	2000-05-26	23
K000447	QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSC	Phamatech	2000-03-07	26
K000131	QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04	Phamatech	2000-02-04	17
K994237	AT HOME DRUG TEST, MODEL 9063	Phamatech	1999-12-30	14
K994236	AT HOME DRUG TEST, MODEL 9133	Phamatech	1999-12-30	14
K994220	AT HOME DRUG TEST, MODEL 9078	Phamatech	1999-12-30	15
K994234	AT HOME DRUG TEST, MODEL 9083	Phamatech	1999-12-30	14
K994233	AT HOME DRUG TEST, MODEL 9068	Phamatech	1999-12-30	14
K994219	AT HOME DRUG TEST, MODEL 9073	Phamatech	1999-12-30	15
K994093	AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C	Phamatech	1999-12-16	13
K993141	AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015	Phamatech	1999-11-08	48
K993165	QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178	Phamatech	1999-10-20	28
K992685	QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C	Phamatech	1999-10-06	57
K992217	AT HOME DRUG TEST, MODEL 9175	Phamatech	1999-07-13	12
K991824	AT HOME DRUG TEST, MODEL 9171	Phamatech	1999-06-11	15
K991641	AT HOME COCAINE & THC SCREENING TEST, MODEL 9170	Phamatech	1999-06-01	20
K991095	QUICKCARD HCG COMBO TEST, MODEL #9014	Phamatech	1999-04-28	27
K990249	OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVUL	Phamatech	1999-03-22	55
K982938	QUICK SCREEN METHADONE SCREENING TEST, MODELS 9035, 9036, QU	Phamatech	1999-02-05	168
K982621	QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150	Phamatech	1998-10-16	80
K982152	QUICK SCREEN BARBITURATE SCREENING TEST MODELS 9020 AND 9021	Phamatech	1998-09-21	95
K981687	QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 902	Phamatech	1998-06-03	21
K980896	QUICKCARD PRO HCG TEST, MODEL 9008	Phamatech	1998-04-02	24
K980865	QUICKSCREEN PRO MULTI DRUG SCREENING TEST , MODEL 9140-9147,	Phamatech	1998-04-01	26
K980532	QUICKSTREAM ONE STEP PREGNANCY TEST MODEL NUMBER 9012	Phamatech	1998-03-11	28
K974582	QUICKSCREEN ONE STEP PCP SCREENING TEST	Phamatech	1998-02-04	58
K974615	QUICKSTICK PRO HCG TEST	Phamatech	1998-01-26	46
K973570	QUICK CARD HCG ONE STEP PREGNANCY TEST	Phamatech	1997-10-31	42
K973122	QUICKSCREEN ONE STEP THC SCREENING TEST	Phamatech	1997-09-25	36
K972556	QUICKSCREEN ONE STEP METHAMPHETAMINE TEST(9065)	Phamatech	1997-09-02	55
K972577	QUICK SCREEN ONE STEP AMPHETAMINE TEST	Phamatech	1997-08-20	41
K972619	QUICKSCREEN ONE STEP OPIATE SCREENING TEST (9080)	Phamatech	1997-08-20	40
K972618	QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)	Phamatech	1997-08-08	28
K972682	QUICKSTICK ONE STEP HCG PREGNANCY TEST	Phamatech	1997-08-01	15
K962219	QUICKSTICK ONE STEP PREGNANCY TEST(9010)	Phamatech	1996-07-23	43

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda