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FDA 510(k)

PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)

K-Number: K954898 · 1996-02-05

ApplicantGenzyme Corp.
Decision Date1996-02-05
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Corp.. It received FDA 510(k) clearance on 1996-02-05 under 510(k) number K954898. 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 PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)?

PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-02-05. The listed applicant is Genzyme Corp.. The 510(k) number is K954898.

When did PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) receive FDA 510(k) clearance?

PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) received FDA 510(k) clearance on 1996-02-05, under 510(k) number K954898.

Who is the listed applicant for PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)?

The FDA 510(k) record lists Genzyme Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)?

The FDA product code for PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) is GGT.

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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.K992799SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KITSangui Biotech, Inc.K983203IMMULITE EPO, MODEL #'S LKEPZ & LKEP1Diagnostic Products Corp.K980737ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAYNichols Institute Diagnostics

Official Source

View on FDA Database →

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

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