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

Name: FDA 510(k) clearance K974306
Creator: U.S. Food and Drug Administration
Published: 1997-12-23

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.. Device class: 2.

Clearance details

Applicant: Sangui Biotech, Inc.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
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 ↗

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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 →

Recalls naming K974306

K-number listed on FDA's recall record

Z-1520-2018 — Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.Class III·Terminated·Diagnostic Hybrids, Inc.·20161026

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K974306.

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