Home / 510(k) Clearances / K842785

510(k) K842785

STAIN, METHYLENE BLUE-EOSIN by Reagent Laboratory, Inc. — Product Code KFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1984
Date Received
July 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methylene Blue, Tissue Stain
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Reagent Laboratory, Inc.

  • K863502 — SOLUTION B- NA 50MEQ/L, K 40 MEQ/L (October 21, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K863550 — POTASSIUM HYDROXIDE 10% W/V (October 2, 1986)
  • K860143 — URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE (February 10, 1986)
  • K842982 — FORMALIN BUFFERED (October 1, 1984)
  • K843050 — GRAM STAIN (September 11, 1984)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K843051 — WRIGHTS STAIN SOLUTION (August 3, 1984)
  • K841799 — CYANOMETHEMOGLOBIN REAGENT (May 31, 1984)
  • K841800 — LYSING & HEMOGLOBIN REAGENT (May 31, 1984)

Other clearances for product code KFC

  • K875310 — RETICULOCYTE STAIN (February 9, 1988)
  • K843919 — SPOTTEST LOEFFLER METHYLENE BLUE STAIN (October 30, 1984)
  • K842926 — METHYLENE BLUE STAIN, LOEFFLER (September 11, 1984)
  • K842743 — NEW METHYLENE BLUE N (August 12, 1984)
  • K831502 — NEPHROLYTE (July 18, 1983)
  • K770792 — TUBE, STAIN, RETICULOCYTE, LARC (July 5, 1977)