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510(k) K881130

CELL-DYN ISOTONIC DILUENT by Abbott Diagnostics — Product Code GIF

K881130 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN ISOTONIC DILUENT". The FDA issued a decision of Substantially Equivalent on March 31, 1988. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Abbott Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1988
Date Received
March 16, 1988
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 Abbott Diagnostics

  • K964185 — IMX CA 125 (November 4, 1997)
  • K972182 — ABBOTT STREP A CONTROLS (August 13, 1997)
  • K961439 — ABBOTT CELL-DYN 4000 SYSTEM (October 18, 1996)
  • K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (April 18, 1989)
  • K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (April 21, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K873408 — MODEL 690 SPECTROPHOTOMETER (September 8, 1987)
  • K872761 — CELL-DYN 610 HEMATOLOGY ANALYZER (August 6, 1987)
  • K870233 — CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (March 17, 1987)

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)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K851280 — DASS PACK (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)
  • K850095 — LASER-DIL (March 29, 1985)

FDA data resources