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FDA 510(k)

EPO-RIA

K-Number: K910481 · 1991-11-29

ApplicantRamco Laboratories, Inc.
Decision Date1991-11-29
Product CodeGGT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

EPO-RIA is the device name listed in this FDA 510(k) record. The listed applicant is Ramco Laboratories, Inc.. It received FDA 510(k) clearance on 1991-11-29 under 510(k) number K910481. 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 EPO-RIA?

EPO-RIA is a medical device that received FDA 510(k) clearance on 1991-11-29. The listed applicant is Ramco Laboratories, Inc.. The 510(k) number is K910481.

When did EPO-RIA receive FDA 510(k) clearance?

EPO-RIA received FDA 510(k) clearance on 1991-11-29, under 510(k) number K910481.

Who is the listed applicant for EPO-RIA?

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

What is the FDA product code for EPO-RIA?

The FDA product code for EPO-RIA is GGT.

Other records listing Ramco Laboratories, 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.

K983107VFEK981208TFRK872941SPECTRO CK864701VWF IMMUNOBLOTK861159SPECTRO VWFK831470PTH MR

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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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