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FDA 510(k)

EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550

K-Number: K883600 · 1989-05-11

ApplicantClinical Sciences, Inc.
Decision Date1989-05-11
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Sciences, Inc.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K883600. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550?

EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Clinical Sciences, Inc.. The 510(k) number is K883600.

When did EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 receive FDA 510(k) clearance?

EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 received FDA 510(k) clearance on 1989-05-11, under 510(k) number K883600.

Who is the listed applicant for EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550?

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

What is the FDA product code for EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550?

The FDA product code for EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550 is LLM.

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Other records listing Clinical Sciences, 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.

K900688VARICELLA ZOSTER IGG CLIN-ELISA TEST KITK883870EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590K883871EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGM #5590K891990RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600K883601EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550K874594TOXOPLASMA IGM CLIN-ELISA(TM) CAT # 5560

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Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K973941IMMUNOWELL EBNA IGG TESTGenbioK980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, 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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