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510(k) K941400

SYNERMED ISE REAGENTS by Synermed, Inc. — Product Code JGS

K941400 is an FDA 510(k) premarket notification submitted by Synermed, Inc. for the device "SYNERMED ISE REAGENTS". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Synermed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1994
Date Received
March 22, 1994
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 Synermed, Inc.

  • K973109 — SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT (September 25, 1997)
  • K972716 — SYNERMED TOTAL BILIRUBIN REAGENT KIT (August 7, 1997)
  • K971491 — SYNERMED IR 200 CHEMISTRY ANALYZER (June 26, 1997)
  • K962479 — SYNERMED ISE REAGENTS (March 3, 1997)
  • K963939 — SYNERMED DIRECT BILIRUBIN REAGENT KIT (December 18, 1996)
  • K960793 — SYNERMED ENZYMATIC CO2 REAGENT KIT (March 11, 1996)
  • K953395 — SYNERMED CALCIUM REAGENT KIT (August 31, 1995)
  • K952179 — SYNERMED ISE REAGENTS (June 20, 1995)
  • K943924 — CREATININE-PO REAGENT KIT (September 20, 1994)
  • K941091 — SYNERMED AMYLASE REAGENT KIT (May 3, 1994)

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