SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA— 510(k) K974306

Substantially Equivalent

Sangui Biotech, Inc.

FDA 510(k) clearance K974306 for SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA, Substantially Equivalent on 1997-12-23. Applicant: Sangui Biotech, Inc..

Clearance details

Applicant: Sangui Biotech, Inc.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 1997-11-17
Decision date: 1997-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.