Reagent Laboratory, Inc.
Mchenry, IL, US
Reagent Laboratory, Inc. appears in FDA device records in Mchenry, IL. FDA records list 19 510(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
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Reagent Laboratory, Inc. between 1984 and 1986. The busiest year on record is 1984, with 15. The most recent is 1986, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 15 |
| 1986 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K863502 | SOLUTION B- NA 50MEQ/L, K 40 MEQ/L | JIX | Substantially Equivalent | |
| K863503 | HEMOLYSE | GGK | Substantially Equivalent | |
| K863550 | POTASSIUM HYDROXIDE 10% W/V | PPM | Substantially Equivalent | |
| K860143 | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE | JJP | Substantially Equivalent | |
| K842982 | FORMALIN BUFFERED | IFP | Substantially Equivalent | |
| K843050 | GRAM STAIN | JTS | Substantially Equivalent | |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | KFC | Substantially Equivalent | |
| K841847 | LITHIUM REAGENT | JJO | Substantially Equivalent | |
| K843051 | WRIGHTS STAIN SOLUTION | Unknown | ||
| K841800 | LYSING & HEMOGLOBIN REAGENT | GGK | Substantially Equivalent | |
| K841799 | CYANOMETHEMOGLOBIN REAGENT | GIF | Substantially Equivalent | |
| K841423 | SCOTTS TAP WATER SUBSTITUTE 7 | JCC | Substantially Equivalent | |
| K841183 | SODIUM CHLORIDE SOLUTION BLOOD CELL | FNW | Substantially Equivalent | |
| K841418 | SODIUM ELECTRODE RINSE SOLUTION 2 | JGS | Substantially Equivalent | |
| K841417 | POTASSIUM CHLORIDE SOLUTION -2 MOLAR | JGS | Substantially Equivalent | |
| K841422 | VOLUME TEST DYE 6 | JJO | Substantially Equivalent | |
| K841421 | DAILY WASH SOLUTION 5 | JJO | Substantially Equivalent | |
| K841420 | SODIUM & POTASSIUM STANDARD SOL 80 | JIX | Substantially Equivalent | |
| K841419 | SODIUM & POTASSIUM STANDARD SOLUT | JIX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JIXCalibrator, Multi-Analyte Mixture
- GIFDiluent, Blood Cell
- JJPElectrode, Ion Selective (Non-Specified)
- JGSElectrode, Ion Specific, Sodium
- JJOFlame Emission Photometer For Clinical Use
- IFPFormalin, Neutral Buffered
- PPMGeneral Purpose Reagent
- KFCMethylene Blue, Tissue Stain
- FNWPad, Kelly
- JCCPh Buffer
- GGKProducts, Red-Cell Lysing Products
- JTSStains, Microbiologic
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