Medical Device Manufacturer · US , Mchenry , IL

Reagent Laboratory, Inc.

19 submissions · 18 cleared · Since 1984
19
Total
18
Cleared
0
Denied

Reagent Laboratory, Inc. — FDA 510(k) Submissions

Reagent Laboratory, Inc. has submitted 19 FDA 510(k) premarket notifications since 1984, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Calibrator, Multi-analyte Mixture, Flame Emission Photometer For Clinical Use, Electrode, Ion Specific, Sodium, Products, Red-cell Lysing Products, Stains, Microbiologic . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
SOLUTION B- NA 50MEQ/L, K 40 MEQ/L
K863502 · JIX Calibrator, Multi-analyte... · Chemistry
Oct 1986 42d
HEMOLYSE
K863503 · GGK Products, Red-cell Lysing... · Hematology
Oct 1986 24d
POTASSIUM HYDROXIDE 10% W/V
K863550 · PPM General Purpose Reagent · Chemistry
Oct 1986 20d
URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE
K860143 · JJP Electrode, Ion Selective... · Chemistry
Feb 1986 26d
FORMALIN BUFFERED
K842982 · IFP Formalin, Neutral Buffered · Pathology
Oct 1984 63d
STAIN, METHYLENE BLUE-EOSIN
K842785 · KFC Methylene Blue, Tissue Stain · Pathology
Sep 1984 71d
GRAM STAIN
K843050 · JTS Stains, Microbiologic · Microbiology
Sep 1984 39d
LITHIUM REAGENT
K841847 · JJO Flame Emission Photometer... · Toxicology
Aug 1984 121d
WRIGHTS STAIN SOLUTION
K843051 · Pathology
Aug 1984
CYANOMETHEMOGLOBIN REAGENT
K841799 · GIF Diluent, Blood Cell · Hematology
May 1984 43d
LYSING & HEMOGLOBIN REAGENT
K841800 · GGK Products, Red-cell Lysing... · Hematology
May 1984 43d
SCOTTS TAP WATER SUBSTITUTE 7
K841423 · JCC Ph Buffer · Pathology
May 1984 47d
SODIUM CHLORIDE SOLUTION BLOOD CELL
K841183 · FNW Pad, Kelly · Hematology
May 1984 62d
POTASSIUM CHLORIDE SOLUTION -2 MOLAR
K841417 · JGS Electrode, Ion Specific,... · Chemistry
May 1984 41d
SODIUM ELECTRODE RINSE SOLUTION 2
K841418 · JGS Electrode, Ion Specific,... · Chemistry
May 1984 41d
SODIUM & POTASSIUM STANDARD SOLUT
K841419 · JIX Calibrator, Multi-analyte... · Chemistry
May 1984 36d
SODIUM & POTASSIUM STANDARD SOL 80
K841420 · JIX Calibrator, Multi-analyte... · Chemistry
May 1984 36d
DAILY WASH SOLUTION 5
K841421 · JJO Flame Emission Photometer... · Chemistry
May 1984 36d
VOLUME TEST DYE 6
K841422 · JJO Flame Emission Photometer... · Chemistry
May 1984 36d
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