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510(k) K974306

SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA by Sangui Biotech, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1997
Date Received
November 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Sangui Biotech, Inc.

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  • K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (September 3, 1998)
  • K982608 — SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT (August 19, 1998)

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