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FDA 510(k)

INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM

K-Number: K040146 · 2004-05-04

ApplicantInterlab S.R.L.
Decision Date2004-05-04
Product CodeGKA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Interlab S.R.L.. It received FDA 510(k) clearance on 2004-05-04 under 510(k) number K040146. The device is classified under product code GKA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM?

INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2004-05-04. The listed applicant is Interlab S.R.L.. The 510(k) number is K040146.

When did INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM receive FDA 510(k) clearance?

INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM received FDA 510(k) clearance on 2004-05-04, under 510(k) number K040146.

Who is the listed applicant for INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM?

The FDA 510(k) record lists Interlab S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM?

The FDA product code for INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM is GKA.

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Other records listing Interlab S.R.L. 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.

K053571MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMK032862INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEMK033187INTERLAB IMMUNOFIXATION TEST(S)

Related Devices (Code: GKA)

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.

K232027CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentSebiaK222635Premier Resolution SystemTrinity Biotech (Primus Corporation, Dba Trinity Biotech)K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlHelena Laboratories, Corp.K180762CAPI 3 HEMOGLOBIN(E)SebiaK171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc.K112550CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEMSebia

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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