Company ยท US
Marion Laboratories, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 1989. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | 3 |
| DKE | Reagents, Test, Tetrahydrocannabinol | 2 |
| JTS | Stains, Microbiologic | 2 |
| JTW | System, Transport, Aerobic | 2 |
| JXA | Kit, Screening, Urine | 2 |
| KEQ | Media, Mounting, Water Soluble | 2 |
| KOZ | Beads, Hydrophilic, For Wound Exudate Absorption | 2 |
| KZJ | Device, Gas Generating | 2 |
| LJF | Device, Antimicrobial Drug Removal | 2 |
| NAD | Dressing, Wound, Occlusive | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| DKJ | Colorimetry, Salicylate | 1 |
| DKK | Tanks, Developing, Tlc | 1 |
| EFQ | Gauze/Sponge, Internal | 1 |
| FRO | Dressing, Wound, Drug | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| HYW | Stain, Trichrome, Mallory'S | 1 |
| IFQ | Formulations, Mercuric Chloride For Tissue | 1 |
| IGM | Solution, Carnoy'S | 1 |
| IPL | Wheelchair, Standup | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 1989 | K883391 | POLYMER ADHESIVE BANDAGE Marion Laboratories, Inc. | NAD |
| Jul 5, 1988 | K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN Marion Laboratories, Inc. | DKE |
| May 27, 1988 | K875181 | MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM Marion Laboratories, Inc. | |
| Mar 11, 1988 | K874554 | ENVICLUSIVE (TM) Marion Laboratories, Inc. | NAD |
| Jan 22, 1988 | K874552 | ENVISAN PAD Marion Laboratories, Inc. | KOZ |
| Jan 22, 1988 | K874551 | ENVINET(TM) Marion Laboratories, Inc. | EFQ |
| Dec 18, 1987 | K874553 | ENVISAN PASTE Marion Laboratories, Inc. | KOZ |
| Apr 14, 1987 | K870864 | CULTURETTE BRAND CDT CLOSTRIDIUM DIFFICILE TEST Marion Laboratories, Inc. | LLH |
| Sep 17, 1986 | K863485 | MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST Marion Laboratories, Inc. | LLH |
| Jun 16, 1986 | K862123 | BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE Marion Laboratories, Inc. | KZJ |
| Aug 1, 1985 | K853073 | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. Marion Laboratories, Inc. | GTZ |
| Jul 19, 1985 | K852044 | CULTURETTE BRAND RAPID LATEX TEST CLOSTRIDIUM TOXI Marion Laboratories, Inc. | LLH |
| Jun 4, 1985 | K851399 | BAC-T-SCREEN Marion Laboratories, Inc. | JXA |
| Mar 5, 1985 | K845008 | BIO-BAG ENVIRONMENTAL CHAMBER -TYPE A-MULTI-PLATE Marion Laboratories, Inc. | KZJ |
| Jan 13, 1984 | K833917 | BAC-T-SCREEN Marion Laboratories, Inc. | JTA |
| Jun 30, 1983 | K831456 | TOXI-LAB CANNABINOID THC SCREEN Marion Laboratories, Inc. | DKE |
| Apr 8, 1983 | K830372 | ARTIMICROBIAL REMOVAL DEVICE Marion Laboratories, Inc. | LJF |
| Mar 1, 1983 | K823850 | BAC-T-SCREEN BACTERIURIA DETECTION DEV Marion Laboratories, Inc. | JXA |
| Jan 14, 1983 | K823523 | TOXI-LAB RAPID SCREEN Marion Laboratories, Inc. | DKJ |
| Aug 25, 1982 | K822344 | ANTIMICROBIAL REMOVAL DEVICE (ARD) Marion Laboratories, Inc. | LJF |
| Nov 2, 1981 | K812919 | MULTI-GRAM DEVELOPING TANK R-12 & R-3 Marion Laboratories, Inc. | DKK |
| Apr 29, 1981 | K811067 | BIO-BAG TM ENVIRONMENTAL CHAMBER TYPE M Marion Laboratories, Inc. | KZT |
| Apr 3, 1981 | K810613 | ANTIMICROBIAL REMOVAL DEVICE Marion Laboratories, Inc. | MDB |
| Jan 12, 1981 | K803298 | MINI-TIP CULTURETTE Marion Laboratories, Inc. | JTW |
| Oct 10, 1980 | K802319 | HEMOTEMP TM Marion Laboratories, Inc. | KSE |
| Apr 4, 1980 | K800052 | ANTIMICROBIAL REMOVAL DEVICE (ARD) Marion Laboratories, Inc. | |
| Jan 24, 1980 | K792654 | CULTURETTE BRAND-PVA/FORMALIN KIT Marion Laboratories, Inc. | IFQ |
| Oct 17, 1979 | K791724 | BIO-BAG ENVIRONMENTAL CHAMBER (A & B) Marion Laboratories, Inc. | JTX |
| May 15, 1979 | K790815 | CULTURETTE BRAND PVA Marion Laboratories, Inc. | IGM |
| Feb 13, 1979 | K790265 | LEVO-STAND-UP WHEELCHAIR Marion Laboratories, Inc. | IPL |
| Dec 13, 1978 | K782016 | SPIROCARE 108-B Marion Laboratories, Inc. | BWF |
| Nov 22, 1978 | K781869 | DROPPER, CEPTI-SEAL KOH SOLUTION Marion Laboratories, Inc. | KEQ |
| Nov 22, 1978 | K781868 | DROPPER, CEPTI-SEAL LAVTOPHENOL Marion Laboratories, Inc. | KEQ |
| Aug 14, 1978 | K781062 | DROPPER, SOLUTION TRICHROME, CEPTI-SEAL Marion Laboratories, Inc. | HYW |
| Aug 14, 1978 | K781061 | DROPPERS, SOLUTION, IODINE Marion Laboratories, Inc. | JTS |
| Apr 10, 1978 | K780440 | CHAMBER, AEROBIC Marion Laboratories, Inc. | JTW |
| Mar 28, 1978 | K780222 | I.V. START KIT Marion Laboratories, Inc. | FRO |
| Mar 22, 1978 | K780346 | MIF PROCEDURE KIT Marion Laboratories, Inc. | JTS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||