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510(k) K760487

HEMASTAIN PHOSPHATE BUFFER by Geometric Data, Div. Smithkline Corp. — Product Code KQC

K760487 is an FDA 510(k) premarket notification submitted by Geometric Data, Div. Smithkline Corp. for the device "HEMASTAIN PHOSPHATE BUFFER". The FDA issued a decision of Substantially Equivalent on August 30, 1976. The device falls under product code KQC (Stains, Hematology), a Class I device regulated under 21 CFR 864.1850. Geometric Data, Div. Smithkline Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1976
Date Received
August 20, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Hematology
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Geometric Data, Div. Smithkline Corp.

  • K841852 — AUTOLYZER 800 (September 5, 1984)
  • K811534 — HEMASPINNER (August 18, 1981)
  • K791041 — HEMATRAK ABNORMAL RECOGNITION (September 4, 1979)
  • K791108 — CONTEXT FILTER (July 17, 1979)
  • K790816 — HEMATRAK MODEL 480 (July 17, 1979)
  • K790042 — STAIN, HEMASTAIN RETIC (February 15, 1979)
  • K780577 — PLATELETS/CU MM (May 19, 1978)
  • K772139 — RE-CELL SLIDE RECAP (January 5, 1978)
  • K761207 — HEMATRAK RBC MORPHOLOGY (October 18, 1977)
  • K770680 — HEMATRAK (July 1, 1977)

Other clearances for product code KQC

  • K882873 — FIELDTEX HEMATOXYLIN (July 28, 1988)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K843619 — RETIC-SET (October 30, 1984)
  • K841848 — RETIC-SET (May 31, 1984)
  • K792550 — PONCEAU S STAIN SET (January 16, 1980)
  • K792496 — VOLU-SOL NMB RETICULOCYTE STAIN (December 31, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K760485 — HEMASTAIN FIXATIVE (August 30, 1976)

FDA data resources