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510(k) K875310

RETICULOCYTE STAIN by Sigma Diagnostics, Inc. — Product Code KFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1988
Date Received
December 29, 1987
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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  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K013549 — SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 (December 26, 2001)
  • K013545 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 (November 15, 2001)
  • K013544 — SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 (November 15, 2001)
  • K012410 — INFINITY HBA KIT, MODELS 537-A, 537-B (October 26, 2001)
  • K010652 — SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 (March 30, 2001)
  • K010158 — THROMBOMAX-HS WITH CALCIUM, MODEL T6540 (March 22, 2001)
  • K003267 — SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A (March 15, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)

Other clearances for product code KFC

  • K843919 — SPOTTEST LOEFFLER METHYLENE BLUE STAIN (October 30, 1984)
  • 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)