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510(k) K851450

FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM by Flow Cytometry Standards Corp. — Product Code JIW

K851450 is an FDA 510(k) premarket notification submitted by Flow Cytometry Standards Corp. for the device "FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM". The FDA issued a decision of Substantially Equivalent on September 16, 1985. The device falls under product code JIW (Calibrator, Surrogate), a Class II device regulated under 21 CFR 862.1150.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1985
Date Received
April 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Surrogate
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances for product code JIW

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  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K910255 — FLOW CYTOMETRY FITC/PE COMPENSATION KIT (April 3, 1991)
  • K902575 — SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) (October 4, 1990)
  • K902294 — ACCUSCAN MICROBEAD STANDARDS (July 3, 1990)
  • K892213 — ACS COLLOID OSMOTIC PRESSURE CALIBRATOR (June 21, 1989)
  • K883389 — RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (December 14, 1988)
  • K882220 — CALIBRATION KIT (August 2, 1988)
  • K880654 — AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200 (June 7, 1988)
  • K880610 — UNIMETER CALIBRATION KIT (March 24, 1988)

FDA data resources