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FDA 510(k)

INDIRECT FLUORESCENT ASSAY FOR (HCMV)

K-Number: K882835 · 1988-12-05

ApplicantStellar Bio Systems, Inc.
Decision Date1988-12-05
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORESCENT ASSAY FOR (HCMV) 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 1988-12-05 under 510(k) number K882835. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT FLUORESCENT ASSAY FOR (HCMV)?

INDIRECT FLUORESCENT ASSAY FOR (HCMV) is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is Stellar Bio Systems, Inc.. The 510(k) number is K882835.

When did INDIRECT FLUORESCENT ASSAY FOR (HCMV) receive FDA 510(k) clearance?

INDIRECT FLUORESCENT ASSAY FOR (HCMV) received FDA 510(k) clearance on 1988-12-05, under 510(k) number K882835.

Who is the listed applicant for INDIRECT FLUORESCENT ASSAY FOR (HCMV)?

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 (HCMV)?

The FDA product code for INDIRECT FLUORESCENT ASSAY FOR (HCMV) is GQH.

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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 1K900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.

View all 7 devices →

Related Devices (Code: GQH)

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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, Inc.K880679BION CMV-G TEST SYSTEMBion Ent., Ltd.

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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