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510(k) K882488

CANTROL HDL CHOLESTEROL PRECIPI. REAG. AND TUBES by Canyon Diagnostics, Inc. — Product Code LBR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1988
Date Received
June 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ldl & Vldl Precipitation, Hdl
Device Class
Class I
Regulation Number
862.1475
Review Panel
CH
Submission Type

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  • K855006 — CANTROL CK/MB CONTROL (January 17, 1986)
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  • K853603 — CANTROL URINE DIPSTICK CONTROL TWO LEVELS (October 8, 1985)
  • K852138 — WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (June 13, 1985)

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