Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1

K-Number: K905608 · 1991-11-07

ApplicantStellar Bio Systems, Inc.
Decision Date1991-11-07
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 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 1991-11-07 under 510(k) number K905608. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1?

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Stellar Bio Systems, Inc.. The 510(k) number is K905608.

When did INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 receive FDA 510(k) clearance?

INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 received FDA 510(k) clearance on 1991-11-07, under 510(k) number K905608.

Who is the listed applicant for INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1?

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 HERPES SIMPLEX 1?

The FDA product code for INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1 is GQL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ANTIBODYK900974INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.K882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)

View all 7 devices →

Related Devices (Code: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, Inc.K904167PATHODX HERPES TYPINGDiagnostic Products Corp.

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.

↑