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 (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST

K-Number: K872056 · 1987-06-15

ApplicantBoots-Celltech Diagnostics, Inc.
Decision Date1987-06-15
Product CodeLJC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) 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 1987-06-15 under 510(k) number K872056. The device is classified under product code LJC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST?

MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST is a medical device that received FDA 510(k) clearance on 1987-06-15. The listed applicant is Boots-Celltech Diagnostics, Inc.. The 510(k) number is K872056.

When did MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST receive FDA 510(k) clearance?

MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST received FDA 510(k) clearance on 1987-06-15, under 510(k) number K872056.

Who is the listed applicant for MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) 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 (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST?

The FDA product code for MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST is LJC.

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: LJC)

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.

K032330CT OIAThermo Biostar, Inc.K033865IDEIA PCE CHLAMYDIADakocytomation, Ltd.K033079CHLAMYDIA IGG ELISA TEST SYSTEMTrinity Biotech USAK982210MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIADade Behring, Inc.K962558CHLAMYDIA IGG ELISA TEST SYSTEMArmkel, LLCK960850ACCESS CHLAMYDIA ASSAYBio-Rad Laboratories, 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.

↑