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510(k) K850209

QUICK-LYTE by Seragen Diagnostics, Inc. — Product Code JGS

K850209 is an FDA 510(k) premarket notification submitted by Seragen Diagnostics, Inc. for the device "QUICK-LYTE". The FDA issued a decision of Substantially Equivalent on February 27, 1985. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Seragen Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1985
Date Received
January 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Ion Specific, Sodium
Device Class
Class II
Regulation Number
862.1665
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)
  • K852260 — QUICK-CHEM CALIBRATION SET (July 22, 1985)
  • K851520 — CK/LD ISOENZYMES CONTROLS(HUMAN) (June 25, 1985)
  • K851521 — LD-1(IMMUNO) SEPARATION SET (May 10, 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 JGS

  • K252475 — ABL90 FLEX PLUS System (May 1, 2026)
  • K230275 — i-STAT CG8+ cartridge with the i-STAT 1 System (October 27, 2023)
  • K222438 — A-LYTE® Integrated Multisensor (IMT Na K Cl) (July 25, 2023)
  • K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer (July 20, 2023)
  • K213486 — GLP systems Track (March 10, 2022)
  • K200403 — Stat Profile Prime Plus Analyzer System (April 14, 2020)
  • K183688 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K191365 — Stat Profile Prime ES Comp Plus Analyzer System (July 19, 2019)
  • K172232 — LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS (June 12, 2019)
  • K183549 — GEM Premier ChemSTAT (February 16, 2019)

FDA data resources