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FDA 510(k)

ANA SCREEN ELISA TEST SYSTEM

K-Number: K940362 · 1994-07-28

ApplicantZeus Scientific, Inc.
Decision Date1994-07-28
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA SCREEN ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1994-07-28 under 510(k) number K940362. 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 ANA SCREEN ELISA TEST SYSTEM?

ANA SCREEN ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-28. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K940362.

When did ANA SCREEN ELISA TEST SYSTEM receive FDA 510(k) clearance?

ANA SCREEN ELISA TEST SYSTEM received FDA 510(k) clearance on 1994-07-28, under 510(k) number K940362.

Who is the listed applicant for ANA SCREEN ELISA TEST SYSTEM?

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

What is the FDA product code for ANA SCREEN ELISA TEST SYSTEM?

The FDA product code for ANA SCREEN ELISA TEST SYSTEM is LLL.

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Other records listing Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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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