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510(k) K813171

PHENYLALANINE UV KINETIC TEST KIT by Biochemicals, Inc. — Product Code JNB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1981
Date Received
November 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Device Class
Class II
Regulation Number
862.1555
Review Panel
CH
Submission Type

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  • K974047 — ACCUWELL PHENYLALANINE ASSAY (December 5, 1997)
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  • K960437 — RADIAS PHENYLALANINE TEST (August 16, 1996)
  • K961515 — QUANTASE PHENYLALANINE ASSAY (June 12, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)