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510(k) K060768

PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS by Abbott Diabetes Care, Inc. — Product Code JIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2006
Date Received
March 22, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1435
Review Panel
CH
Submission Type

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  • K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips f (July 6, 2017)
  • K033114 — KETOCHECKS (April 26, 2004)
  • K003987 — URS-1K (KETONE TESST) (April 26, 2001)
  • K953662 — FIRST CHOICE KETONES URINE TEST STRIPS (June 14, 1996)
  • K953680 — FIRST CHOICE GLUCOSE & KETONES URINE TEST STRIPS (June 12, 1996)