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

Marion Laboratories, Inc. · Predicate Candidate Screening

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

46 daysmedian FDA review time

128 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days
K883391	POLYMER ADHESIVE BANDAGE	Marion Laboratories, Inc.	1989-03-23	226
K875182	MODIFIED LABELING FOR TOXI-LAB THC SCREEN	Marion Laboratories, Inc.	1988-07-05	201
K875181	MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM	Marion Laboratories, Inc.	1988-05-27	162
K874554	ENVICLUSIVE (TM)	Marion Laboratories, Inc.	1988-03-11	128
K874551	ENVINET(TM)	Marion Laboratories, Inc.	1988-01-22	79
K874552	ENVISAN PAD	Marion Laboratories, Inc.	1988-01-22	79
K874553	ENVISAN PASTE	Marion Laboratories, Inc.	1987-12-18	44
K870864	CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST	Marion Laboratories, Inc.	1987-04-14	42
K863485	MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST	Marion Laboratories, Inc.	1986-09-17	8
K862123	BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE	Marion Laboratories, Inc.	1986-06-16	13
K853073	CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.	Marion Laboratories, Inc.	1985-08-01	9
K852044	CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI	Marion Laboratories, Inc.	1985-07-19	71
K851399	BAC-T-SCREEN	Marion Laboratories, Inc.	1985-06-04	56
K845008	BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE	Marion Laboratories, Inc.	1985-03-05	69
K833917	BAC-T-SCREEN	Marion Laboratories, Inc.	1984-01-13	60
K831456	TOXI-LAB CANNABINOID THC SCREEN	Marion Laboratories, Inc.	1983-06-30	55
K830372	ARTIMICROBIAL REMOVAL DEVICE	Marion Laboratories, Inc.	1983-04-08	63
K823850	BAC-T-SCREEN BACTERIURIA DETECTION DEV	Marion Laboratories, Inc.	1983-03-01	70
K823523	TOXI-LAB RAPID SCREEN	Marion Laboratories, Inc.	1983-01-14	46
K822344	ANTIMICROBIAL REMOVAL DEVICE (ARD)	Marion Laboratories, Inc.	1982-08-25	20
K812919	MULTI-GRAM DEVELOPING TANK R-12 & R-3	Marion Laboratories, Inc.	1981-11-02	14
K811067	BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M	Marion Laboratories, Inc.	1981-04-29	12
K810613	ANTIMICROBIAL REMOVAL DEVICE	Marion Laboratories, Inc.	1981-04-03	28
K803298	MINI-TIP CULTURETTE	Marion Laboratories, Inc.	1981-01-12	13
K802319	HEMOTEMP TM	Marion Laboratories, Inc.	1980-10-10	17
K800052	ANTIMICROBIAL REMOVAL DEVICE (ARD)	Marion Laboratories, Inc.	1980-04-04	86
K792654	CULTURETTE BRAND-PVA/FORMALIN KIT	Marion Laboratories, Inc.	1980-01-24	29
K791724	BIO-BAG ENVIRONMENTAL CHAMBER (A & B)	Marion Laboratories, Inc.	1979-10-17	48
K790815	CULTURETTE BRAND PVA	Marion Laboratories, Inc.	1979-05-15	18
K790265	LEVO-STAND-UP WHEELCHAIR	Marion Laboratories, Inc.	1979-02-13	7
K782016	SPIROCARE 108-B	Marion Laboratories, Inc.	1978-12-13	8
K781868	DROPPER, CEPTI-SEAL LAVTOPHENOL	Marion Laboratories, Inc.	1978-11-22	19
K781869	DROPPER, CEPTI-SEAL KOH SOLUTION	Marion Laboratories, Inc.	1978-11-22	19
K781062	DROPPER, SOLUTION TRICHROME, CEPTI-SEAL	Marion Laboratories, Inc.	1978-08-14	49
K781061	DROPPERS, SOLUTION, IODINE	Marion Laboratories, Inc.	1978-08-14	49
K780440	CHAMBER, AEROBIC	Marion Laboratories, Inc.	1978-04-10	21
K780222	I.V. START KIT	Marion Laboratories, Inc.	1978-03-28	47
K780346	MIF PROCEDURE KIT	Marion Laboratories, Inc.	1978-03-22	21

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