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510(k) K842926

METHYLENE BLUE STAIN, LOEFFLER by E K Ind., Inc. — Product Code KFC

K842926 is an FDA 510(k) premarket notification submitted by E K Ind., Inc. for the device "METHYLENE BLUE STAIN, LOEFFLER". 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. E K Ind., 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 25, 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 E K Ind., Inc.

  • K842931 — DRABKIN REAGENT (September 21, 1984)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842934 — DECOLORIZING FLUIC, ACID-ALCOHOL 3% (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)
  • K842935 — ACETIC ACID, 5% V/V (September 12, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842927 — LIGHT GREEN SF 1% (September 11, 1984)
  • K842731 — FORMALIN-ACETO-ALCOHOL FIXATIVE (September 11, 1984)
  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842930 — GOMORI'S TRICHROME STAIN (September 11, 1984)

Other clearances for product code KFC

  • K875310 — RETICULOCYTE STAIN (February 9, 1988)
  • K843919 — SPOTTEST LOEFFLER METHYLENE BLUE STAIN (October 30, 1984)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (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