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FDA 510(k)

EL-ANA PROFILES: EL-ENA/5

K-Number: K982622 · 1998-08-13

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

Device Summary

EL-ANA PROFILES: EL-ENA/5 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 K982622. 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/5?

EL-ANA PROFILES: EL-ENA/5 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 K982622.

When did EL-ANA PROFILES: EL-ENA/5 receive FDA 510(k) clearance?

EL-ANA PROFILES: EL-ENA/5 received FDA 510(k) clearance on 1998-08-13, under 510(k) number K982622.

Who is the listed applicant for EL-ANA PROFILES: EL-ENA/5?

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/5?

The FDA product code for EL-ANA PROFILES: EL-ENA/5 is LLL.

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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

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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.

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