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510(k) K875029

ABBOTT BREATH ACETONE ANALYZER by Abbott Laboratories — Product Code JIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1988
Date Received
December 7, 1987
Clearance Type
Traditional
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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Other clearances for product code JIN

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  • K170587 — On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips f (July 6, 2017)
  • K060768 — PRECISION XTRA BLOOD B KETONE TEST STRIPS, OPTIUM BLOOD B KETONE TEST STRIPS (April 21, 2006)
  • K033114 — KETOCHECKS (April 26, 2004)
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