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510(k) K811534

HEMASPINNER by Geometric Data, Div. Smithkline Corp. — Product Code GKJ

K811534 is an FDA 510(k) premarket notification submitted by Geometric Data, Div. Smithkline Corp. for the device "HEMASPINNER". The FDA issued a decision of Substantially Equivalent on August 18, 1981. The device falls under product code GKJ (Spinner, Slide, Automated), a Class I device regulated under 21 CFR 864.5850. Geometric Data, Div. Smithkline Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1981
Date Received
June 1, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinner, Slide, Automated
Device Class
Class I
Regulation Number
864.5850
Review Panel
HE
Submission Type

Other clearances by Geometric Data, Div. Smithkline Corp.

  • K841852 — AUTOLYZER 800 (September 5, 1984)
  • 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)
  • K770550 — ATYPIA PROFILE MONITOR (June 17, 1977)

Other clearances for product code GKJ

  • K854962 — MICRO-MAT SYSTEM (December 23, 1985)
  • K854121 — MICRO-MAT SYSTEM (October 31, 1985)
  • K831558 — E-Z PREP (June 16, 1983)
  • K771898 — AUTOMATED SLIDE SPINNER (October 18, 1977)
  • K760007 — BLOOD-SMEARING INSTRUMENT (MINIPREP TM) (September 3, 1976)

FDA data resources