Home / 510(k) Clearances / K790442

510(k) K790442

ISOTONIC DILUENT by Royco Instruments — Product Code GIF

K790442 is an FDA 510(k) premarket notification submitted by Royco Instruments for the device "ISOTONIC DILUENT". The FDA issued a decision of Substantially Equivalent on April 4, 1979. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Royco Instruments has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1979
Date Received
March 7, 1979
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 Royco Instruments

  • K800104 — ROYCO MODEL 951 CELL MIXER (February 6, 1980)
  • K791867 — ROYCO MODEL 921 CELL COUNTER (November 5, 1979)
  • K791644 — ROYCO MODEL 371 SUPER DILUTOR (September 19, 1979)

Other clearances for product code GIF

  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (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