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510(k) K831617

DILUENT by Omega Medical Diagnostics — Product Code GIF

K831617 is an FDA 510(k) premarket notification submitted by Omega Medical Diagnostics for the device "DILUENT". The FDA issued a decision of Substantially Equivalent on June 16, 1983. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Omega Medical Diagnostics has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1983
Date Received
May 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diluent, Blood Cell
Device Class
Class I
Regulation Number
864.8200
Review Panel
HE
Submission Type

Other clearances by Omega Medical Diagnostics

  • K832182 — LYSING REAGENT (August 12, 1983)
  • K831620 — SODIUM HYPOCHLORITE 3% (July 28, 1983)
  • K831619 — SODIUM HYPOCHLORITE 7% (July 28, 1983)
  • K831618 — HEMOGLOBIN REAGENT (June 16, 1983)

Other clearances for product code GIF

  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT (July 25, 1988)
  • K882267 — SYSMEX QUICKLYSER-II (QLS-200A) (July 12, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851280 — DASS PACK (July 5, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)

FDA data resources