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FDA 510(k)

SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA

K-Number: K974306 · 1997-12-23

ApplicantSangui Biotech, Inc.
Decision Date1997-12-23
Product CodeCEW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Sangui Biotech, Inc.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K974306. The device is classified under product code CEW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA?

SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Sangui Biotech, Inc.. The 510(k) number is K974306.

When did SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA receive FDA 510(k) clearance?

SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA received FDA 510(k) clearance on 1997-12-23, under 510(k) number K974306.

Who is the listed applicant for SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA?

The FDA 510(k) record lists Sangui Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA?

The FDA product code for SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA is CEW.

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Other records listing Sangui Biotech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K001943CHRONALCO I.D.CDT (CARBOHYDRATE DEFICIENT TRANSFERRIN) ASSAYK992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITK982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITK982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KIT

Related Devices (Code: CEW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231927Elecsys PTH , Elecsys PTH STATRoche DiagnosticsK232791Access Intact PTHBeckman Coulter, Inc.K221197VITROS Immunodiagnostic Products Intact PTH II Reagent PackOrtho Clinical DiagnosticsK190702Lumipulse G whole PTHFujirebio Diagnostics,Inc.K163658ADVIA Centaur Intact Parathyroid Hormone (PTH) AssaySiemens Healthcare Diagnostics, Inc.K161158IDS-iSYS Intact PTHNImmunodiagnostic Systems , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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