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510(k) K833677

QUICK STAIN WRIGHT'S GIEMSA W/BUFF by J.S. Medical Assoc. — Product Code HYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1983
Date Received
October 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Giemsa Stain
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by J.S. Medical Assoc.

  • K932752 — VISI-SPOT (November 5, 1993)
  • K932688 — EYE SPOT IM TEST (September 8, 1993)
  • K932180 — EYE SPOT CRP TEST (August 23, 1993)
  • K932551 — ACCUTEX IM LATEX TEST (August 9, 1993)
  • K926112 — ACCUTEX BETA-HCG TEST (July 28, 1993)
  • K924332 — ACCUTEX CRP LATEX TEST (December 7, 1992)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K924036 — ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST (December 1, 1992)
  • K924037 — ACCUTEX IM RBC TEST (November 2, 1992)
  • K924248 — ACCUTEX SLE LATEX TEST (November 2, 1992)

Other clearances for product code HYF

  • K842742 — GIEMSA STAIN (August 15, 1984)
  • K833665 — HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK (November 25, 1983)
  • K831131 — CASE WRIGHT-GIEMSA STAIN PAK (June 8, 1983)