Concord Laboratories, Inc.
Mchenry, IL, US
Concord Laboratories, Inc. appears in FDA device records in Mchenry, IL. FDA records list 42 510(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
- 42
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 42 510(k) clearances for Concord Laboratories, Inc. between 1976 and 1989. The busiest year on record is 1977, with 14. The most recent is 1989, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 5 |
| 1977 | 14 |
| 1978 | 2 |
| 1980 | 1 |
| 1981 | 2 |
| 1983 | 2 |
| 1984 | 9 |
| 1985 | 2 |
| 1986 | 2 |
| 1987 | 2 |
| 1989 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K883840 | DRI-VENT ARTERIAL BLOOD SAMPLING KIT | LKB | Unknown | |
| K871825 | MECONIUM SUCTION CATHETER | BSY | Substantially Equivalent | |
| K864535 | TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 | BSY | Substantially Equivalent | |
| K862039 | CONCORD CARE TRAY | Unknown | ||
| K854601 | SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH | BSO | Substantially Equivalent | |
| K854327 | SUBCUTANEOUS TUNNELING NEEDLES & HANDLES | GCB | Substantially Equivalent | |
| K851134 | REGIONAL ANESTHESIA TRAYS | CAZ | Unknown | |
| K842095 | EPIDURAL TRAYS | CAZ | Substantially Equivalent | |
| K841486 | ARTERIAL BLOOD SAMPLING KITS | CBT | Substantially Equivalent | |
| K840987 | VAPORIZED HEPARIN | CBT | Substantially Equivalent | |
| K840986 | PREFILLED PULSATOR SYRINGE | CBT | Substantially Equivalent | |
| K840709 | MID-STREAM URINE COLLECTION SETS | Substantially Equivalent | ||
| K833814 | SANI CATCH BA | LIO | Substantially Equivalent | |
| K840988 | NO POUR BASIN | Unknown | ||
| K833993 | ALCOHOL SWABS | LKB | Substantially Equivalent | |
| K833936 | ACETONE ALCOHOL SWABS | LKB | Substantially Equivalent | |
| K833582 | PULSATOR ARTERIAL BLOOD SAMPLING SYRIN | CBT | Substantially Equivalent | |
| K832778 | EPIDURAL SYRINGE | CAZ | Substantially Equivalent | |
| K811009 | PREFILLED PULSATOR SYRINGE | FMF | Substantially Equivalent | |
| K810995 | PREFILLED PULSATOR SYRINGE | FMF | Substantially Equivalent | |
| K801814 | CATHETER SUCTION TRACHEOBRONCHIAL | BSY | Substantially Equivalent | |
| K782090 | CLAMP, DISPOSABLE | HXD | Substantially Equivalent | |
| K780419 | SUBCLAVIAN TRAY | KGO | Substantially Equivalent | |
| K772218 | CATHETER, SILICONE COATED | EZL | Substantially Equivalent | |
| K771667 | BLOOD GAS TRAY #4024 | FMI | Substantially Equivalent | |
| K771673 | CATHETEO CARE TRAY #0242 | FMC | Substantially Equivalent | |
| K770850 | TRAY, BLOOD GAS, ARTERIAL, #4014 | FMF | Substantially Equivalent | |
| K770852 | SYRINGE, BLOOD SAMPLING, ARTERIAL, #4015 | FMF | Substantially Equivalent | |
| K770851 | SYRINGE, BLOOD SAMPLING, ARTERIAL, #4016 | FMF | Substantially Equivalent | |
| K771104 | URETHRAL TRAY W/OUT CAHTETER, 7650 | FCM | Substantially Equivalent | |
| K771103 | URETHRAL TRAY W/CATHETER, 7750 | FCM | Substantially Equivalent | |
| K770673 | COLLECTOR, SANI-CATCH, NO. 1014 | KNX | Substantially Equivalent | |
| K770672 | COLLECTOR, SANI-CATCH, NO. 1010 | KNX | Substantially Equivalent | |
| K770361 | TRAY, BLOOD GAS, CAT. NO. 4010 | FMF | Substantially Equivalent | |
| K770557 | DRAINAGE BAG, 4000 ML. | KNX | Substantially Equivalent | |
| K770497 | DRAINAGE UNIT, COMBINATION | KNX | Substantially Equivalent | |
| K770496 | UNIVERSAL TRAY | FCM | Substantially Equivalent | |
| K760128 | TRAY, CATHETERIZATION W/ CATHETER | FCM | Substantially Equivalent | |
| K760127 | TRAY, CATHETERIZATION W/O CATHETER | FCM | Substantially Equivalent | |
| K760105 | BAG, URINE COLLECTION, CLOSED SYSTEM | KNX | Substantially Equivalent | |
| K760085 | BASIN, STERILE (#3200) | FNY | Substantially Equivalent | |
| K760086 | TRAY, BLOOD SAMPLING (PULSATOR II) | GJE | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CAZAnesthesia Conduction Kit
- CBTArterial Blood Sampling Kit
- FNYBasin, Emesis
- BSOCatheter, Conduction, Anesthetic
- EZLCatheter, Retention Type, Balloon
- BSYCatheters, Suction, Tracheobronchial
- HXDClamp
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- LIODevice, Specimen Collection
- GCBNeedle, Catheter
- FMINeedle, Hypodermic, Single Lumen
- LKBPad, Alcohol, Device Disinfectant
- FMCPatient Examination Glove
- KGOSurgeon'S Gloves
- FMFSyringe, Piston
- GJETray, Blood Collection
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
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