Reagent Laboratory, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
19
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LOctober 21, 1986
K863503HEMOLYSEOctober 3, 1986
K863550POTASSIUM HYDROXIDE 10% W/VOctober 2, 1986
K860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEFebruary 10, 1986
K842982FORMALIN BUFFEREDOctober 1, 1984
K842785STAIN, METHYLENE BLUE-EOSINSeptember 11, 1984
K843050GRAM STAINSeptember 11, 1984
K841847LITHIUM REAGENTAugust 17, 1984
K843051WRIGHTS STAIN SOLUTIONAugust 3, 1984
K841800LYSING & HEMOGLOBIN REAGENTMay 31, 1984
K841799CYANOMETHEMOGLOBIN REAGENTMay 31, 1984
K841423SCOTTS TAP WATER SUBSTITUTE 7May 22, 1984
K841183SODIUM CHLORIDE SOLUTION BLOOD CELLMay 21, 1984
K841417POTASSIUM CHLORIDE SOLUTION -2 MOLARMay 16, 1984
K841418SODIUM ELECTRODE RINSE SOLUTION 2May 16, 1984
K841419SODIUM & POTASSIUM STANDARD SOLUTMay 11, 1984
K841420SODIUM & POTASSIUM STANDARD SOL 80May 11, 1984
K841421DAILY WASH SOLUTION 5May 11, 1984
K841422VOLUME TEST DYE 6May 11, 1984