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510(k) K843919

SPOTTEST LOEFFLER METHYLENE BLUE STAIN by Difco Laboratories, Inc. — Product Code KFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1984
Date Received
October 5, 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

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Other clearances for product code KFC

  • K875310 — RETICULOCYTE STAIN (February 9, 1988)
  • K842785 — STAIN, METHYLENE BLUE-EOSIN (September 11, 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)