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510(k) K813412

GLUCOSE ENZYME-COLOR REAGENT SET by Diagnostic Specialties — Product Code CGA

K813412 is an FDA 510(k) premarket notification submitted by Diagnostic Specialties for the device "GLUCOSE ENZYME-COLOR REAGENT SET". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Diagnostic Specialties has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 4, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Diagnostic Specialties

  • K971458 — ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT (September 2, 1997)
  • K941001 — ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT (August 30, 1994)
  • K930823 — PROTEIN-BOUND GLUCOSE ASSAYN KIT (August 19, 1993)
  • K922032 — ENZIP URINARY MICROALBUMIN TEST (July 30, 1992)
  • K831180 — PREGNA-CERT, SLIDE PREGNANCY TEST (May 27, 1983)
  • K823109 — GENERIC PREGNANCY TEST (November 10, 1982)
  • K813608 — POTASSIUM REAGENT SET (January 22, 1982)

Other clearances for product code CGA

  • K252488 — ABL90 FLEX PLUS System (May 1, 2026)
  • K210933 — YSI 2900C Biochemistry Analyzer (September 30, 2024)
  • K220328 — EasyStat 300 (July 26, 2024)
  • K223179 — Cholestech LDX ™ System (September 20, 2023)
  • K223755 — i-STAT G cartridge with the i-STAT 1 System (September 11, 2023)
  • K223710 — i-STAT CG8+ cartridge with the i-STAT 1 System (July 28, 2023)
  • K223090 — GEM Premier ChemSTAT (January 27, 2023)
  • K203549 — Nova Primary Glucose Analyzer System (October 18, 2022)
  • K210958 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (August 13, 2021)
  • K200349 — Stat Profile Prime Plus Analyzer System (March 13, 2020)

FDA data resources