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)

EL-ANA PROFILES: EL-ENA/4

K-Number: K982150 · 1998-08-13

ApplicantTheratest Laboratories, Inc.
Decision Date1998-08-13
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EL-ANA PROFILES: EL-ENA/4 is the device name listed in this FDA 510(k) record. The listed applicant is Theratest Laboratories, Inc.. It received FDA 510(k) clearance on 1998-08-13 under 510(k) number K982150. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EL-ANA PROFILES: EL-ENA/4?

EL-ANA PROFILES: EL-ENA/4 is a medical device that received FDA 510(k) clearance on 1998-08-13. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K982150.

When did EL-ANA PROFILES: EL-ENA/4 receive FDA 510(k) clearance?

EL-ANA PROFILES: EL-ENA/4 received FDA 510(k) clearance on 1998-08-13, under 510(k) number K982150.

Who is the listed applicant for EL-ANA PROFILES: EL-ENA/4?

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

What is the FDA product code for EL-ANA PROFILES: EL-ENA/4?

The FDA product code for EL-ANA PROFILES: EL-ENA/4 is LLL.

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 Theratest Laboratories, 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.

K090753THERATEST EL-ANTI-CCP/2K090760THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120K071692THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMSK061376EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3K060176EL-ACL SCREEN; EL-ACL IGM, IGG, IGAK051066THERATEST EL-ANA PROFILES

View all 22 devices →

Related Devices (Code: LLL)

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.

K253817IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/LaImmunodiagnostics Systems LimitedK253367EliA CTD 13 ScreenPhadia ABK250666Alegria Flash CTD ScreenZeus ScientificK250408Alegria Flash ENA ScreenZeus ScientificK213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.K190710EliA SymphonyS ImmunoassayPhadia AB

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.

↑