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

Smithkline Diagnostics, Inc. — Predicate Candidate Screening

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

35 daysmedian FDA review time

108 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days
K961062	FLEXSURE OBT	Smithkline Diagnostics, Inc.	1996-11-06	233
K960183	FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGN	Smithkline Diagnostics, Inc.	1996-06-07	143
K934863	FLEXSURE HP	Smithkline Diagnostics, Inc.	1994-05-18	218
K880499	HEMOCCULT SENSITIVE TEST	Smithkline Diagnostics, Inc.	1988-05-23	108
K875131	(SKD) CHOLESTEROL TEST KIT	Smithkline Diagnostics, Inc.	1988-03-01	77
K862849	HEMOCCULT WIPE TEST	Smithkline Diagnostics, Inc.	1986-12-09	133
K854723	SKD ELECTROCHEMICAL SYSTEM (ECS)	Smithkline Diagnostics, Inc.	1986-03-05	103
K852841	RAPID DIRECT STREP A LATEX AGGLUTINATION TEST	Smithkline Diagnostics, Inc.	1985-07-24	19
K821884	GASTROCCULT TM	Smithkline Diagnostics, Inc.	1982-10-08	105
K821674	SPINCHEM ACID PHOSPHATASE REAGENT	Smithkline Diagnostics, Inc.	1982-06-22	15
K821184	SPIN CHEM REAGENTS & STANDARDS	Smithkline Diagnostics, Inc.	1982-05-24	27
K821183	TARGET ISOCHECK CONTROL SERUM	Smithkline Diagnostics, Inc.	1982-05-14	17
K812646	SKI 5000	Smithkline Diagnostics, Inc.	1981-11-16	60
K812472	SPIN-CHEM LD-L REAGENT	Smithkline Diagnostics, Inc.	1981-09-14	14
K812471	SPIN-CHEM TRIGLYCERIDES REAGENT	Smithkline Diagnostics, Inc.	1981-09-14	14
K811850	ESKAFLOW TEST FOR TRIGLYCERIDES	Smithkline Diagnostics, Inc.	1981-07-23	22
K811849	ESKAFLOW TEST FOR GLUCOSE	Smithkline Diagnostics, Inc.	1981-07-15	14
K810914	5CM SMALL PARTS SCANNER	Smithkline Diagnostics, Inc.	1981-05-08	32
K803234	ESKACHEM PAP REAGENT	Smithkline Diagnostics, Inc.	1981-02-26	66
K801060	HIGH RESOLUTION 10CM DIAG. ULTRA. SCANNE	Smithkline Diagnostics, Inc.	1980-06-04	29
K800824	MODEL SKI-200 ABDOMINAL SCANNER	Smithkline Diagnostics, Inc.	1980-05-14	30
K800531	S.K. DIAG. ULTRASND. SMALL PARTS SCAN	Smithkline Diagnostics, Inc.	1980-04-10	34
K800532	S.K. DIAG. ULTRASOUND BODY SCANNER	Smithkline Diagnostics, Inc.	1980-04-10	34
K792023	ESKACHEM, CK-MB REAGENT	Smithkline Diagnostics, Inc.	1979-10-30	21
K791080	PLUS CHEM S.C.E. REAGENT	Smithkline Diagnostics, Inc.	1979-07-24	42
K791083	SPIN CHEM, DETERMINATION OF ALT (GPT)	Smithkline Diagnostics, Inc.	1979-07-17	35
K791084	PLUS CHEM, DETERMINATION OF ALT (GPT)	Smithkline Diagnostics, Inc.	1979-07-17	35
K791082	SPIN CHEM REAGENT, DETERMINATION OF AST	Smithkline Diagnostics, Inc.	1979-07-17	35
K791081	SPIN CHEM REAGENT, DETERMINATION OF LDH-	Smithkline Diagnostics, Inc.	1979-07-17	35
K791085	PLUS CHEM, DETERMINATION OF LD (LDH-P)	Smithkline Diagnostics, Inc.	1979-07-17	35
K790917	SPIN CHEM CK-NAC REAGENT	Smithkline Diagnostics, Inc.	1979-06-22	39
K790918	ESKLAB REAGENT TABLETS	Smithkline Diagnostics, Inc.	1979-06-22	39
K790916	CK-NUC REAGENT	Smithkline Diagnostics, Inc.	1979-06-22	39
K772121	ASPIRATOR & PROBE, CYTOLOGY, ENDOMET.	Smithkline Diagnostics, Inc.	1977-11-17	7
K770767	IN VITRO DIAG. FOR URIC ACID	Smithkline Diagnostics, Inc.	1977-07-05	68
K770483	CHOLESTEROL REAGENT	Smithkline Diagnostics, Inc.	1977-06-08	86
K761180	SIGMOIDOSCOPE/ DISPOSABLE	Smithkline Diagnostics, Inc.	1977-01-05	34
K761052	REAL TIME OBSTETRICAL ULTRASONIC SCANNER	Smithkline Diagnostics, Inc.	1976-12-16	31
K761030	EKOSECTOR I	Smithkline Diagnostics, Inc.	1976-12-13	31
K760057	TEST, RIA, TRIODOTHYRONINE	Smithkline Diagnostics, Inc.	1976-09-13	89
K760055	REAGENT, GLUCOSE, FLOW-THROUGH ANALYZER	Smithkline Diagnostics, Inc.	1976-08-26	71
K760077	TEST, RIA, SERUM DIGOXIN	Smithkline Diagnostics, Inc.	1976-07-16	28

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