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FDA 510(k)

ORGENTEC ABTI-SS-BB(LA) ELISA

K-Number: K962052 · 1996-11-15

ApplicantAmerican Laboratory Products Co., Ltd.
Decision Date1996-11-15
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ORGENTEC ABTI-SS-BB(LA) ELISA is the device name listed in this FDA 510(k) record. The listed applicant is American Laboratory Products Co., Ltd.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K962052. 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 ORGENTEC ABTI-SS-BB(LA) ELISA?

ORGENTEC ABTI-SS-BB(LA) ELISA is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is American Laboratory Products Co., Ltd.. The 510(k) number is K962052.

When did ORGENTEC ABTI-SS-BB(LA) ELISA receive FDA 510(k) clearance?

ORGENTEC ABTI-SS-BB(LA) ELISA received FDA 510(k) clearance on 1996-11-15, under 510(k) number K962052.

Who is the listed applicant for ORGENTEC ABTI-SS-BB(LA) ELISA?

The FDA 510(k) record lists American Laboratory Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORGENTEC ABTI-SS-BB(LA) ELISA?

The FDA product code for ORGENTEC ABTI-SS-BB(LA) ELISA is LJM.

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Other records listing American Laboratory Products Co., Ltd. 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.

K012576CIC-C1Q EIAK011415ALPCO MILENIA ANTI-TG EIAK011201ALPCO MILENIA ANTI-TPO ELISAK974701ORGENTEC ANTI-MPO (P-ANCA) ELISAK974702ORGENTEC ANTI-PR3 (C-ANCA) ELISAK972190THYROGLOBULIN ASSAY SYSTEM

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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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