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FDA 510(k)

THERATEST KIT (MODIFICATION)

K-Number: K955481 · 1996-03-06

ApplicantTheratest Laboratories, Inc.
Decision Date1996-03-06
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THERATEST KIT (MODIFICATION) 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 1996-03-06 under 510(k) number K955481. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERATEST KIT (MODIFICATION)?

THERATEST KIT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1996-03-06. The listed applicant is Theratest Laboratories, Inc.. The 510(k) number is K955481.

When did THERATEST KIT (MODIFICATION) receive FDA 510(k) clearance?

THERATEST KIT (MODIFICATION) received FDA 510(k) clearance on 1996-03-06, under 510(k) number K955481.

Who is the listed applicant for THERATEST KIT (MODIFICATION)?

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 THERATEST KIT (MODIFICATION)?

The FDA product code for THERATEST KIT (MODIFICATION) is LJM.

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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: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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