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FDA 510(k)

EA-D IGG ELISA TEST SYSTEM

K-Number: K973123 · 1998-03-26

ApplicantClark Laboratories, Inc.
Decision Date1998-03-26
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EA-D IGG ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Clark Laboratories, Inc.. It received FDA 510(k) clearance on 1998-03-26 under 510(k) number K973123. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EA-D IGG ELISA TEST SYSTEM?

EA-D IGG ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-26. The listed applicant is Clark Laboratories, Inc.. The 510(k) number is K973123.

When did EA-D IGG ELISA TEST SYSTEM receive FDA 510(k) clearance?

EA-D IGG ELISA TEST SYSTEM received FDA 510(k) clearance on 1998-03-26, under 510(k) number K973123.

Who is the listed applicant for EA-D IGG ELISA TEST SYSTEM?

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

What is the FDA product code for EA-D IGG ELISA TEST SYSTEM?

The FDA product code for EA-D IGG ELISA TEST SYSTEM is LSE.

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Other records listing Clark 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.

K980912VCA IGG ELISA TEST SYSTEMK980596VCA IGM ELISA TEST SYSTEMK980598EBNA-1 IGM ELISA TEST SYSTEMK931543ENCORE ENA COMBINED EIAK925826ENCORE THYROGLOBULIN IGE, IGA AND IGM EIAK923537ENCORE DS-DNA

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Related Devices (Code: LSE)

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.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc.

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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