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510(k) K880266

MULTI-ENZYME LINEARITY SOLUTION by Verichem Laboratories, Inc. — Product Code JJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1988
Date Received
January 22, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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  • K882059 — BILIRUBIN STANDARD (October 25, 1988)
  • K881320 — URINE TOXICOLOGY STANDARD (September 9, 1988)
  • K875285 — MULTI-CHEMISTRY LINEARITY STANDARD (September 2, 1988)

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