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510(k) K171476

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) by Awareness Technology, Inc. — Product Code JGS

K171476 is an FDA 510(k) premarket notification submitted by Awareness Technology, Inc. for the device "SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)". The FDA issued a decision of Substantially Equivalent on February 27, 2018. The device falls under product code JGS (Electrode, Ion Specific, Sodium), a Class II device regulated under 21 CFR 862.1665. Awareness Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2018
Date Received
May 19, 2017
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 Awareness Technology, Inc.

  • K013420 — CHEMWELL, ALSO KNOWN AS PROJECT 2900 (July 19, 2002)
  • K010877 — CHEMWELL, MODEL 2900 (May 23, 2001)
  • K974762 — STAT TRACKS (January 28, 1998)
  • K943729 — DYE CHECK STRIPS 545-630 (December 29, 1994)
  • K941394 — STAT FAX 2600 (June 3, 1994)
  • K923598 — REDI-CHECK PHOTMETER Q.A. (October 14, 1992)
  • K900224 — STAT FAX(TM)-2100 (March 1, 1990)
  • K892656 — DRI-DYE CHECK STRIPS (TM)-405 (May 22, 1989)
  • K882938 — STAT FAX(TM) (September 9, 1988)
  • K873451 — PROJECT 300 MICROASSAY BP-12, EIA MINILAB (November 4, 1987)

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