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FDA 510(k)

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.

K-Number: K900974 · 1990-04-16

ApplicantStellar Bio Systems, Inc.
Decision Date1990-04-16
Product CodeJRY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. is the device name listed in this FDA 510(k) record. The listed applicant is Stellar Bio Systems, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K900974. The device is classified under product code JRY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.?

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Stellar Bio Systems, Inc.. The 510(k) number is K900974.

When did INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. receive FDA 510(k) clearance?

INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. received FDA 510(k) clearance on 1990-04-16, under 510(k) number K900974.

Who is the listed applicant for INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.?

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

What is the FDA product code for INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.?

The FDA product code for INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI. is JRY.

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Other records listing Stellar Bio Systems, 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.

K992587EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEMK990916INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODYK990915INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODYK914953IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODYK905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1K882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)

View all 7 devices →

Related Devices (Code: JRY)

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.

K042118ATHENA MULTI-LYTE EBV IGG TEST SYSTEMZeus Scientific, Inc.K891785BION EBV-G (VCA) TEST SYSTEMBion Ent., Ltd.K884829EBV EARLY ANTIGEN (R+D)Hillcrest BiologicalsK822734EBV IGM TESTGull Laboratories, Inc.K822985EBV-M KITLitton BioneticsK821849EBV-VCA ANTIBODY ASSAY KITBiotech Research 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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