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510(k) K790042

STAIN, HEMASTAIN RETIC by Geometric Data, Div. Smithkline Corp. — Product Code GJH

K790042 is an FDA 510(k) premarket notification submitted by Geometric Data, Div. Smithkline Corp. for the device "STAIN, HEMASTAIN RETIC". The FDA issued a decision of Substantially Equivalent on February 15, 1979. The device falls under product code GJH (Stain, Reticulocyte), 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
February 15, 1979
Date Received
January 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stain, Reticulocyte
Device Class
Class I
Regulation Number
864.1850
Review Panel
HE
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)
  • 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)

FDA data resources