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)

CYTOMEGELISA M TEST KIT

K-Number: K854839 · 1986-02-04

ApplicantWhittaker Bioproducts, Inc.
Decision Date1986-02-04
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGELISA M TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1986-02-04 under 510(k) number K854839. The device is classified under product code LKQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGELISA M TEST KIT?

CYTOMEGELISA M TEST KIT is a medical device that received FDA 510(k) clearance on 1986-02-04. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K854839.

When did CYTOMEGELISA M TEST KIT receive FDA 510(k) clearance?

CYTOMEGELISA M TEST KIT received FDA 510(k) clearance on 1986-02-04, under 510(k) number K854839.

Who is the listed applicant for CYTOMEGELISA M TEST KIT?

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

What is the FDA product code for CYTOMEGELISA M TEST KIT?

The FDA product code for CYTOMEGELISA M TEST KIT is LKQ.

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 Whittaker Bioproducts, 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.

K911356LEGIONELLA STAT IGG/IGM TEST KITK9132123M IGE SINGLE POINT FAST TESTK904652LYME STAT M TEST KITK904893FIAX LYME M TEST KITK911473EBNA STAT TEST KITK905468PYLORI-G FIAX TEST KIT

View all 30 devices →

Related Devices (Code: LKQ)

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.

K100433IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,Siemens Healthcare DiagnosticsK972884ACCURUN 146 CMV IGM POSITIVE CONTROLBoston Biomedica, Inc.K933549VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc.K922580BARTELS CYTOMEGALOVIRUS IGM EIABaxter Diagnostics, Inc.K914789ELISA CMV IGMSclavo, Inc.K913080OPUS(R) ANTI CMV-MPb Diagnostics, 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.

↑