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510(k) K873348

CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. by Abbott Diagnostics — Product Code GGK

K873348 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.". The FDA issued a decision of Substantially Equivalent on September 9, 1987. The device falls under product code GGK (Products, Red-Cell Lysing Products), a Class I device regulated under 21 CFR 864.8540. Abbott Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1987
Date Received
August 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Red-Cell Lysing Products
Device Class
Class I
Regulation Number
864.8540
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)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (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 GGK

  • K883836 — COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II (November 30, 1988)
  • K883991 — KVM HEMOGLOBIN LYSING REAGENT (October 12, 1988)
  • K874054 — FISHER DIAGNOSTICS HEMATALL III LAS REAGENT (October 20, 1987)
  • K863114 — PIASTRINIT (November 6, 1986)
  • K863503 — HEMOLYSE (October 3, 1986)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K842938 — ACETIC ACID 1% V/V (September 14, 1984)
  • K842937 — ACETIC ACID 2% V/V (September 12, 1984)
  • K842936 — ACETIC ACID, 3% V/V (September 12, 1984)

FDA data resources