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510(k) K882059

BILIRUBIN STANDARD by Verichem Laboratories, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1988
Date Received
May 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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  • K881320 — URINE TOXICOLOGY STANDARD (September 9, 1988)
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