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)

HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING

K-Number: K904095 · 1991-02-01

ApplicantCalifornia Integrated Diagnostics, Inc.
Decision Date1991-02-01
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING is the device name listed in this FDA 510(k) record. The listed applicant is California Integrated Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-02-01 under 510(k) number K904095. 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 HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING?

HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING is a medical device that received FDA 510(k) clearance on 1991-02-01. The listed applicant is California Integrated Diagnostics, Inc.. The 510(k) number is K904095.

When did HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING receive FDA 510(k) clearance?

HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING received FDA 510(k) clearance on 1991-02-01, under 510(k) number K904095.

Who is the listed applicant for HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING?

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

What is the FDA product code for HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING?

The FDA product code for HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING 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 California Integrated Diagnostics, 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.

K874259TRICHOMONAS DIRECT ENZYME IMMUNOASSAYK871278MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KITK871279MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT

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.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, 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.

↑