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FDA 510(k)

SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT

K-Number: K992799 · 2000-06-07

ApplicantSangui Biotech, Inc.
Decision Date2000-06-07
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT 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 2000-06-07 under 510(k) number K992799. The device is classified under product code GGT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT?

SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT is a medical device that received FDA 510(k) clearance on 2000-06-07. The listed applicant is Sangui Biotech, Inc.. The 510(k) number is K992799.

When did SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT receive FDA 510(k) clearance?

SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT received FDA 510(k) clearance on 2000-06-07, under 510(k) number K992799.

Who is the listed applicant for SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT?

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. EPO (ERYTHROPOIETIN) ELISA KIT?

The FDA product code for SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT is GGT.

Related Clinical Trials

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.

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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) ASSAYK982491SANGUI BIOTECH, INC. CALCITONIN ELISA KITK982608SANGUI BIOTECH, INC. ACTH (ADRENOCORTICOTROPIC HORMONE) ELISA KITK974306SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA

Related Devices (Code: GGT)

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.

K240182Access EPOBeckman Coulter, Inc.K183088ADVIA Centaur Erythropoietin (EPO) assayAxis-Shield Diagnostics LimitedK052223ACCESS EPO ASSAYBeckman Coulter, Inc.K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.K980737ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYNichols Institute DiagnosticsK952559ERYTHROPOIETIN IMMUNOASSAY KITNichols Institute

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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