Medical Device Manufacturer · US , Mchenry , IL

Marion Laboratories, Inc.

38 submissions · 34 cleared · Since 1978
38
Total
34
Cleared
0
Denied

Marion Laboratories, Inc. — FDA 510(k) Submissions

Marion Laboratories, Inc. has submitted 38 FDA 510(k) premarket notifications since 1978, of which 34 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagents, Clostridium Difficile Toxin, Kit, Screening, Urine, Reagents, Test, Tetrahydrocannabinol, Device, Gas Generating, Stains, Microbiologic . Use the specialty filter in the sidebar to narrow results.

38 devices
1–25 of 38
POLYMER ADHESIVE BANDAGE
K883391 · NAD Dressing, Wound, Occlusive · General & Plastic Surgery
Mar 1989 226d
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · DKE Reagents, Test,... · Toxicology
Jul 1988 201d
MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM
K875181 · Toxicology
May 1988 162d
ENVICLUSIVE (TM)
K874554 · NAD Dressing, Wound, Occlusive · General & Plastic Surgery
Mar 1988 128d
ENVINET(TM)
K874551 · EFQ Gauze/sponge, Internal · General & Plastic Surgery
Jan 1988 79d
ENVISAN PAD
K874552 · KOZ Beads, Hydrophilic, For... · General & Plastic Surgery
Jan 1988 79d
ENVISAN PASTE
K874553 · KOZ Beads, Hydrophilic, For... · General & Plastic Surgery
Dec 1987 44d
CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST
K870864 · LLH Reagents, Clostridium... · Microbiology
Apr 1987 42d
MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST
K863485 · LLH Reagents, Clostridium... · Microbiology
Sep 1986 8d
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
K862123 · KZJ Device, Gas Generating · Microbiology
Jun 1986 13d
CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D.
K853073 · GTZ Antisera, All Groups,... · Microbiology
Aug 1985 9d
CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI
K852044 · LLH Reagents, Clostridium... · Microbiology
Jul 1985 71d
BAC-T-SCREEN
K851399 · JXA Kit, Screening, Urine · Microbiology
Jun 1985 56d
BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE
K845008 · KZJ Device, Gas Generating · Microbiology
Mar 1985 69d
BAC-T-SCREEN
K833917 · JTA Monitor, Microbial Growth · Chemistry
Jan 1984 60d
TOXI-LAB CANNABINOID THC SCREEN
K831456 · DKE Reagents, Test,... · Toxicology
Jun 1983 55d
ARTIMICROBIAL REMOVAL DEVICE
K830372 · LJF Device, Antimicrobial... · Microbiology
Apr 1983 63d
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · JXA Kit, Screening, Urine · Microbiology
Mar 1983 70d
TOXI-LAB RAPID SCREEN
K823523 · DKJ Colorimetry, Salicylate · Toxicology
Jan 1983 46d
ANTIMICROBIAL REMOVAL DEVICE (ARD)
K822344 · LJF Device, Antimicrobial... · Microbiology
Aug 1982 20d
MULTI-GRAM DEVELOPING TANK R-12 & R-3
K812919 · DKK Tanks, Developing, Tlc · Toxicology
Nov 1981 14d
BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M
K811067 · KZT Kit, Disc, Agar Gel... · Microbiology
Apr 1981 12d
ANTIMICROBIAL REMOVAL DEVICE
K810613 · MDB System, Blood Culturing · Microbiology
Apr 1981 28d
MINI-TIP CULTURETTE
K803298 · JTW System, Transport, Aerobic · Microbiology
Jan 1981 13d
HEMOTEMP TM
K802319 · KSE Refrigerator, Freezer,... · Hematology
Oct 1980 17d
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