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510(k) K833665

HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK by J.S. Medical Assoc. — Product Code HYF

K833665 is an FDA 510(k) premarket notification submitted by J.S. Medical Assoc. for the device "HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK". The FDA issued a decision of Substantially Equivalent on November 25, 1983. The device falls under product code HYF (Giemsa Stain), a Class I device regulated under 21 CFR 864.1850. J.S. Medical Assoc. has at least 10 other 510(k) clearances on record.

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)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K924332 — ACCUTEX CRP 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)
  • K833677 — QUICK STAIN WRIGHT'S GIEMSA W/BUFF (November 25, 1983)
  • K831131 — CASE WRIGHT-GIEMSA STAIN PAK (June 8, 1983)

FDA data resources