Marion Laboratories, Inc.
Medical device manufacturer in Kansas City, MI.
38510(k) clearances
0PMA approvals
0recalls
Device types
- LLH Reagents, Clostridium Difficile Toxin 3
- JTW System, Transport, Aerobic 2
- KZJ Device, Gas Generating 2
- KEQ Media, Mounting, Water Soluble 2
- KOZ Beads, Hydrophilic, For Wound Exudate… 2
- DKE Reagents, Test, Tetrahydrocannabinol 2
- JXA Kit, Screening, Urine 2
- NAD Dressing, Wound, Occlusive 2
- LJF Device, Antimicrobial Drug Removal 2
- JTS Stains, Microbiologic 2
- KSE Refrigerator, Freezer, Blood Storage 1
- DKK Tanks, Developing, Tlc 1
- KZT Kit, Disc, Agar Gel Diffusion, Determine… 1
- MDB System, Blood Culturing 1
- IFQ Formulations, Mercuric Chloride For Tissue 1
- JTX Transport Systems, Anaerobic 1
- IGM Solution, Carnoy'S 1
- IPL Wheelchair, Standup 1
- BWF Spirometer, Therapeutic (Incentive) 1
- HYW Stain, Trichrome, Mallory'S 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
| K853073 | Culturette Brand 10-MINUTE Group a Strep I.D.GTZ · Traditional | 08/01/1985SE |
| K852044 | Culturette Brand Rapid Latex Test Clostridium ToxiLLH · Traditional | 07/19/1985SE |
| K851399 | Bac-T-ScreenJXA · Traditional | 06/04/1985SE |
| K845008 | Bio-Bag Environmental Chamber -Type A-Multi-PlateKZJ · Traditional | 03/05/1985SE |
| K833917 | Bac-T-ScreenJTA · Traditional | 01/13/1984SE |
| K831456 | Toxi-Lab Cannabinoid THC ScreenDKE · Traditional | 06/30/1983SE |
| K830372 | Artimicrobial Removal DeviceLJF · Traditional | 04/08/1983SE |
| K823850 | Bac-T-Screen Bacteriuria Detection DevJXA · Traditional | 03/01/1983SE |
| K823523 | Toxi-Lab Rapid ScreenDKJ · Traditional | 01/14/1983SE |
| K822344 | Antimicrobial Removal Device (Ard)LJF · Traditional | 08/25/1982SE |
| K812919 | Multi-Gram Developing Tank R-12 & R-3DKK · Traditional | 11/02/1981SE |
| K811067 | Bio-Bag TM Environmental Chamber Type MKZT · Traditional | 04/29/1981SE |
| K810613 | Antimicrobial Removal DeviceMDB · Traditional | 04/03/1981SE |
| K803298 | Mini-Tip CulturetteJTW · Traditional | 01/12/1981SE |
| K802319 | Hemotemp TMKSE · Traditional | 10/10/1980SE |
| K800052 | Antimicrobial Removal Device (Ard) · Traditional | 04/04/1980SE |
| K792654 | Culturette Brand-Pva/Formalin KitIFQ · Traditional | 01/24/1980SE |
| K791724 | Bio-Bag Environmental Chamber (a & B)JTX · Traditional | 10/17/1979SE |
| K790815 | Culturette Brand PvaIGM · Traditional | 05/15/1979SE |
| K790265 | Levo-Stand-Up WheelchairIPL · Traditional | 02/13/1979SE |
| K782016 | Spirocare 108-BBWF · Traditional | 12/13/1978SE |
| K781869 | Dropper, Cepti-Seal Koh SolutionKEQ · Traditional | 11/22/1978SE |
| K781868 | Dropper, Cepti-Seal LavtophenolKEQ · Traditional | 11/22/1978SE |
| K781062 | Dropper, Solution Trichrome, Cepti-SealHYW · Traditional | 08/14/1978SE |
| K781061 | Droppers, Solution, IodineJTS · Traditional | 08/14/1978SE |
| K780440 | Chamber, AerobicJTW · Traditional | 04/10/1978SE |
| K780222 | I.V. Start KitFRO · Traditional | 03/28/1978SE |
| K780346 | Mif Procedure KitJTS · Traditional | 03/22/1978SE |