Jelco Laboratories
Mchenry, IL, US
Jelco Laboratories appears in FDA device records in Mchenry, IL. FDA records list 26 510(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
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Jelco Laboratories between 1976 and 1979. The busiest year on record is 1977, with 8. The most recent is 1979, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 7 |
| 1977 | 8 |
| 1978 | 3 |
| 1979 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K791918 | JELCO WINGED INTRAVASCULAR CATHETER | FOZ | Substantially Equivalent | |
| K791372 | JELCO & KVO CATHETER PLACEMENT UNIT | JCY | Substantially Equivalent | |
| K790967 | CATHETER METAL HUB/RADIOPAQUE | FOZ | Substantially Equivalent | |
| K790968 | CATHETER METAL HUB/NONRADIOPAQUE | FOZ | Substantially Equivalent | |
| K790471 | JELCO* DISC FILTER-0.2 MICRON | FPB | Substantially Equivalent | |
| K790186 | PROTECTIVSTABILIZER | GBJ | Substantially Equivalent | |
| K790107 | CATHETER TUBING MODIFICATION | DQO | Substantially Equivalent | |
| K790079 | NEEDLE, BLOOD COLLECTING | GAA | Substantially Equivalent | |
| K781857 | TRAY, ARTERIAL BLOOD GAS SAMPLING | CBT | Substantially Equivalent | |
| K780896 | NEEDLES, DESIGN CHANGE, IV CATHETERS | GCB | Substantially Equivalent | |
| K780519 | FILTER TUBE | BSN | Substantially Equivalent | |
| K771874 | J-VAC VACUUM TUBE | GIM | Substantially Equivalent | |
| K771536 | AIR VENT FILTER NEEDLE, 0.45 | FPB | Substantially Equivalent | |
| K771827 | INTRAVENOUS FILTER W/FLASH BULB | FPB | Substantially Equivalent | |
| K771826 | INTRAVENOUS FILTER W/AUTO AIR VENT | FPB | Substantially Equivalent | |
| K771381 | IV CATHETER HUB | FOZ | Substantially Equivalent | |
| K771551 | I.V. PREP & CARE KIT | FRL | Substantially Equivalent | |
| K770589 | FILTER, INTRAVENOUS W/AUTO AIR VENT | FPA | Substantially Equivalent | |
| K770119 | I.V. LOK TM | KMK | Substantially Equivalent | |
| K760319 | KIT, CATHETER | FOZ | Substantially Equivalent | |
| K760022 | NEEDLE, FILTER | GAA | Substantially Equivalent | |
| K760019 | VACUUM TUBES, PEDIATRIC SIZES (J-VAC) | GIM | Substantially Equivalent | |
| K760018 | VACUUM TUBES, STERILE (J-VAC) | GIM | Substantially Equivalent | |
| K760111 | FILTER, I.V., WITH FLASH BULB (#4701) | FPA | Substantially Equivalent | |
| K760110 | FILTER, I.V. (#4700) | FPA | Substantially Equivalent | |
| K760103 | CAP, INJECTION (#4600) | FPA | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CBTArterial Blood Sampling Kit
- JCYCatheter, Infusion
- DQOCatheter, Intravascular, Diagnostic
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- KMKDevice, Intravascular Catheter Securement
- FRLFiber, Medical, Absorbent
- BSNFilter, Conduction, Anesthetic
- FPBFilter, Infusion Line
- GAANeedle, Aspiration And Injection, Disposable
- GCBNeedle, Catheter
- GBJProsthesis, Adhesive, External
- FPASet, Administration, Intravascular
- GIMTubes, Vacuum Sample, With Anticoagulant
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