The Healthcare Group Laboratories, Inc.
Mchenry, IL, US
The Healthcare Group Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for The Healthcare Group Laboratories, Inc. between 1980 and 1985. The busiest year on record is 1980, with 16. The most recent is 1985, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 16 |
| 1982 | 8 |
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K850035 | EMPTY SOLUTION TRANSFER CONTAINER | KPE | Substantially Equivalent | |
| K842170 | EMPTY SOLUTION TRANSFER CONTAINER | KPE | Substantially Equivalent | |
| K842091 | DISPOS. ACU-CUT SOFT TISSUE BIOPSY | Substantially Equivalent | ||
| K840742 | RIGHT ATRIAL CATHETER | LJS | Substantially Equivalent | |
| K830299 | SOLUTION TRANSFER CONTAINER | KPE | Substantially Equivalent | |
| K822307 | ADHESIVE SPRAY #4050-4060 | KNX | Substantially Equivalent | |
| K822059 | SHOW'RBAG | LGF | Substantially Equivalent | |
| K821480 | RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT | DQY | Substantially Equivalent | |
| K821230 | SOFTIC 49 | EBI | Substantially Equivalent | |
| K821162 | ADHESIVE REMOVER | KOX | Substantially Equivalent | |
| K821172 | EXTERNAL FEMALE URINARY INCONTINENCE | KNX | Substantially Equivalent | |
| K821171 | URINARY COLLECTION CONTAINER/LEG BAG | KNX | Substantially Equivalent | |
| K821161 | EXTERNAL URINARY MALE INCONTINENCE DEV | KNX | Substantially Equivalent | |
| K802585 | FEEDING TUBES IN SILICONE 5,6,8&10 SIZES | KNT | Substantially Equivalent | |
| K801787 | URINARY CATHETER CARE TRAYS #3700&3710 | KOD | Substantially Equivalent | |
| K801785 | URETHRAL CATHETERIZATION TRAYS | KOD | Substantially Equivalent | |
| K800956 | DOUCH TRAY-DISPOSABLE VAGINAL TRAY W/BEN | HED | Substantially Equivalent | |
| K800954 | DOUCHE TRAY-DISPOS. VAGINAL TRAY W/POVID | HED | Substantially Equivalent | |
| K801786 | URINE COLLECTION CONTAINERS, #3600 &3610 | KOD | Substantially Equivalent | |
| K801784 | URINARY CATHETERS #3400,3410 &3420 | KOD | Substantially Equivalent | |
| K801783 | CATHETER IRRIGATION TRAYS, #3300, 3310 & | EYN | Substantially Equivalent | |
| K801782 | GENERAL PURPOSE IRRIGATING/ASPIR SYR. | KQT | Substantially Equivalent | |
| K801781 | CATHETER IRRIGATION SYRINGES, #3100,3110 | KQT | Substantially Equivalent | |
| K800957 | DOUCHE UNIT-1500 ML DISP. CONTAINER | HED | Substantially Equivalent | |
| K800955 | TUBE FEEDING CONTAINER 1500 ML DISPOSE. | KNT | Substantially Equivalent | |
| K800961 | ENEMA CONTAINER DISP. FOR EMEMA ADMIN. | FCE | Substantially Equivalent | |
| K800960 | 1500 ML DISPOSABLE ENEMA CONTAINER(1110) | FCE | Substantially Equivalent | |
| K800959 | LARGE VOLUME ENEMA CONTAINER DISPOSABLE | FCE | Substantially Equivalent | |
| K800958 | PERSONAL SITZ BATH KIT | KTC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTCBath, Sitz, Nonpowered
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- DQYCatheter, Percutaneous
- KODCatheter, Urological
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- LGFComponent, Cast
- KPEContainer, I.V.
- HEDDouche Apparatus, Vaginal, Therapeutic
- FCEEnema Kit
- KQTEvacuator, Gastro-Urology
- EBIResin, Denture, Relining, Repairing, Rebasing
- KOXSolvent, Adhesive Tape
- EYNTray, Irrigation, Sterile
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain