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510(k) K840948

CLEAR POROUS PLASTIC-HYPOALLERGENIC by Gainor Medical — Product Code GKX

K840948 is an FDA 510(k) premarket notification submitted by Gainor Medical for the device "CLEAR POROUS PLASTIC-HYPOALLERGENIC". The FDA issued a decision of Substantially Equivalent on August 14, 1984. The device falls under product code GKX (Instrument, Automated Platelet Counting), a Class II device regulated under 21 CFR 864.5200. Gainor Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1984
Date Received
July 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Automated Platelet Counting
Device Class
Class II
Regulation Number
864.5200
Review Panel
HE
Submission Type

Other clearances by Gainor Medical

  • K850100 — BLOOD LANCET (January 29, 1987)
  • K850150 — ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED (February 21, 1985)
  • K844305 — GAINOR MEDICAL FLOWMAX NEEDLES (November 30, 1984)
  • K844306 — GAINOR MEDICAL SYRINGE (November 30, 1984)
  • K840945 — SKIN CLOSURE (October 31, 1984)
  • K840950 — ZINC OXIDE TAPE (October 31, 1984)
  • K840951 — FIRST AID BANDAGE (October 31, 1984)
  • K840947 — CLOTH-HYPOALLERGENIC (August 17, 1984)
  • K840946 — MICROPOROUS HYPOALLERGENIC (August 17, 1984)
  • K840949 — CLEAR PLASTIC-HYPOALLERGENIC (August 17, 1984)

Other clearances for product code GKX

  • K014203 — ABX MICROS 60 HEMATOLOGY ANALYZER (February 28, 2002)

FDA data resources