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510(k) K001427

MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM by Selfcare, Inc. — Product Code CGA

K001427 is an FDA 510(k) premarket notification submitted by Selfcare, Inc. for the device "MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on June 2, 2000. The device falls under product code CGA (Glucose Oxidase, Glucose), a Class II device regulated under 21 CFR 862.1345. Selfcare, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 2000
Date Received
May 5, 2000
Clearance Type
Special
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 Selfcare, Inc.

  • K002867 — INVERNESS MEDICAL OVULATION PREDICTOR TEST (October 12, 2000)
  • K002134 — ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM (August 7, 2000)
  • K002049 — INVERNESS MEDICAL EARLY PREGNANCY TEST (July 27, 2000)
  • K000583 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (March 17, 2000)
  • K993632 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (November 12, 1999)
  • K991480 — EXCEL GE BLOOD GLUCOSE TEST STRIPS & CODE STRIP (September 17, 1999)
  • K991386 — EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATI (May 25, 1999)
  • K991466 — EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), O (May 25, 1999)
  • K990939 — FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (April 20, 1999)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)

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