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510(k) K852260

QUICK-CHEM CALIBRATION SET by Seragen Diagnostics, Inc. — Product Code JIW

K852260 is an FDA 510(k) premarket notification submitted by Seragen Diagnostics, Inc. for the device "QUICK-CHEM CALIBRATION SET". The FDA issued a decision of Substantially Equivalent on July 22, 1985. The device falls under product code JIW (Calibrator, Surrogate), a Class II device regulated under 21 CFR 862.1150. Seragen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1985
Date Received
May 24, 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 by Seragen Diagnostics, Inc.

  • K872148 — VIVID CHLAMYDIA(TM) (August 19, 1987)
  • K851663 — QUICK-COUNT HEMATOLOGY CONTROLS (July 23, 1985)
  • K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN) (June 25, 1985)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 1985)
  • K850209 — QUICK-LYTE (February 27, 1985)
  • K844743 — SERATEST ENA(RNP/SM) DETERMINATION (February 4, 1985)
  • K842563 — SERATEST DNA DETERMINATION (October 25, 1984)
  • K841504 — QUICK-COUNT PLUS 2 (June 11, 1984)
  • K840793 — CK/MB IMMUNO-ISOENZYME CONTROL SERUM (April 13, 1984)
  • K840863 — SERATEST RF LATEX DETERMINATION (April 4, 1984)

Other clearances for product code JIW

  • K973055 — WAKO CH50 LINEARITY SET (September 25, 1997)
  • 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