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)

MODIFIED IMAGEN(TM) CHLAMYDIA TEST

K-Number: K864539 · 1987-03-12

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1987-03-12
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED IMAGEN(TM) CHLAMYDIA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Boots-Celltech Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-03-12 under 510(k) number K864539. The device is classified under product code LJP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED IMAGEN(TM) CHLAMYDIA TEST?

MODIFIED IMAGEN(TM) CHLAMYDIA TEST is a medical device that received FDA 510(k) clearance on 1987-03-12. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K864539.

When did MODIFIED IMAGEN(TM) CHLAMYDIA TEST receive FDA 510(k) clearance?

MODIFIED IMAGEN(TM) CHLAMYDIA TEST received FDA 510(k) clearance on 1987-03-12, under 510(k) number K864539.

Who is the listed applicant for MODIFIED IMAGEN(TM) CHLAMYDIA TEST?

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

What is the FDA product code for MODIFIED IMAGEN(TM) CHLAMYDIA TEST?

The FDA product code for MODIFIED IMAGEN(TM) CHLAMYDIA TEST is LJP.

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 Boots-Celltech 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.

K871877IDEIA HERPES SIMPLEX VIRUS TESTK880799MODIFIED IDEIA CHLAMYDIA TESTK880758SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAYK874875CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)K872958IMAGEN INFLUENZA VIRUS A AND B TESTMIK872843OVEIA (TM) DUAL ANALYTE

View all 20 devices →

Related Devices (Code: LJP)

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.

K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITDiagnostic Hybrids, Inc.K941714CHLAMYDIA TRACHOMATIS ANTIGEN TESTNeogenexK901243CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TESTCel Labs Pty, Ltd.K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTDiagnostic Products Corp.K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1Diagnostic Products Corp.K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTIWhittaker Bioproducts, 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.

↑