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FDA Submission Data – 510(k) K992799 (Biomerica, Inc.)
FDA Submission Data – 510(k) K992799 (Biomerica, Inc.)
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510(K) Number: K992799
Device Name: SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
Manufacturer: SANGUI BIOTECH, INC.
Device Classification Name: Assay, Erythropoietin
Regulation Number: 864.7250
Classification Product Code: GGT
Date Received: 08/19/1999
Decision Date: 06/07/2000
Regulation Medical Specialty: Hematology
Request Contents: FDA submission data for 510(k) K992799. Current manufacturer: Biomerica, Inc. FDA Establishment Registration: 2025099. Device Listing: D021318.
Device Name: SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
Manufacturer: SANGUI BIOTECH, INC.
Device Classification Name: Assay, Erythropoietin
Regulation Number: 864.7250
Classification Product Code: GGT
Date Received: 08/19/1999
Decision Date: 06/07/2000
Regulation Medical Specialty: Hematology
Request Contents: FDA submission data for 510(k) K992799. Current manufacturer: Biomerica, Inc. FDA Establishment Registration: 2025099. Device Listing: D021318.
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