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510(k) K881242

CELL-DYN RAPID-LYSE AND HEMOGLOBLIN by Abbott Diagnostics — Product Code GJZ

K881242 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "CELL-DYN RAPID-LYSE AND HEMOGLOBLIN". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code GJZ (Cyanomethemoglobin Reagent And Standard Solution), a Class II device regulated under 21 CFR 864.7500. Abbott Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1988
Date Received
March 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cyanomethemoglobin Reagent And Standard Solution
Device Class
Class II
Regulation Number
864.7500
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)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • 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 GJZ

  • K883683 — HEMOGLOBIN (October 6, 1988)

FDA data resources