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510(k) K842785

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

K842785 is an FDA 510(k) premarket notification submitted by Reagent Laboratory, Inc. for the device "STAIN, METHYLENE BLUE-EOSIN". The FDA issued a decision of Substantially Equivalent on September 11, 1984. The device falls under product code KFC (Methylene Blue, Tissue Stain), a Class I device regulated under 21 CFR 864.1850. Reagent Laboratory, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources