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510(k) K990939

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1999
Date Received
March 22, 1999
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)
  • K001427 — MODIFICATION TO FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM (June 2, 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)
  • K983468 — FASTTAKE ADAPTER, MODEL # P/N 020-072-01 (December 17, 1998)

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