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FDA 510(k)

ANTI-EPSTEIN-BARR VIRUS KIT

K-Number: K842662 · 1985-12-12

ApplicantAmico Lab, Inc.
Decision Date1985-12-12
Product CodeGNP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTI-EPSTEIN-BARR VIRUS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amico Lab, Inc.. It received FDA 510(k) clearance on 1985-12-12 under 510(k) number K842662. The device is classified under product code GNP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-EPSTEIN-BARR VIRUS KIT?

ANTI-EPSTEIN-BARR VIRUS KIT is a medical device that received FDA 510(k) clearance on 1985-12-12. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842662.

When did ANTI-EPSTEIN-BARR VIRUS KIT receive FDA 510(k) clearance?

ANTI-EPSTEIN-BARR VIRUS KIT received FDA 510(k) clearance on 1985-12-12, under 510(k) number K842662.

Who is the listed applicant for ANTI-EPSTEIN-BARR VIRUS KIT?

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

What is the FDA product code for ANTI-EPSTEIN-BARR VIRUS KIT?

The FDA product code for ANTI-EPSTEIN-BARR VIRUS KIT is GNP.

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Other records listing Amico Lab, 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.

K842661ANTI-CYTOMEGALOVIRUS KITK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842529AMIZYME-CMV KITK842530AMIZYME-EBV TEST KITK842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842660ANTI-SCHISTOSOMA SPECIES KIT

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Related Devices (Code: GNP)

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K020706EBV-VCA IGG ELISA TEST, MODEL EBG-100Pan Bio Pty. , Ltd.K020707EBV-EBNA IGG ELISA KIT, MODEL EBG-100Pan Bio Pty. , Ltd.K020717EBV V VCA IGM ELISA KIT MODEL# EBM-200Pan Bio Pty. , Ltd.K981831IS EBV-EA-D IGG ELISA TEST SYSTEMDiamedix Corp.K981829IS EBV-EBNA-1 IGG ELISA TEST SYSTEMDiamedix Corp.K901156EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUMGranbio, 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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