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510(k) K033114

KETOCHECKS by Neo Diagnostics, Inc. — Product Code JIN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2004
Date Received
September 30, 2003
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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  • K003987 — URS-1K (KETONE TESST) (April 26, 2001)
  • K953662 — FIRST CHOICE KETONES URINE TEST STRIPS (June 14, 1996)
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