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FDA 510(k)

DIAZYME LITHIUM ENZYMATIC ASSAY KIT

K-Number: K033360 · 2003-12-23

ApplicantGeneral Atomics
Decision Date2003-12-23
Product CodeJII
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DIAZYME LITHIUM ENZYMATIC ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is General Atomics. It received FDA 510(k) clearance on 2003-12-23 under 510(k) number K033360. The device is classified under product code JII. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIAZYME LITHIUM ENZYMATIC ASSAY KIT?

DIAZYME LITHIUM ENZYMATIC ASSAY KIT is a medical device that received FDA 510(k) clearance on 2003-12-23. The listed applicant is General Atomics. The 510(k) number is K033360.

When did DIAZYME LITHIUM ENZYMATIC ASSAY KIT receive FDA 510(k) clearance?

DIAZYME LITHIUM ENZYMATIC ASSAY KIT received FDA 510(k) clearance on 2003-12-23, under 510(k) number K033360.

Who is the listed applicant for DIAZYME LITHIUM ENZYMATIC ASSAY KIT?

The FDA 510(k) record lists General Atomics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIAZYME LITHIUM ENZYMATIC ASSAY KIT?

The FDA product code for DIAZYME LITHIUM ENZYMATIC ASSAY KIT is JII.

Related Clinical Trials

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Other records listing General Atomics 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.

K082488DIAZYME LP(A) ASSAYK072977DIAZYME APOLIPOPROTEIN A-1 ASSAYK072523DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLSK050178HBA1C ENZYMATIC ASSAYK042448DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

Related Devices (Code: JII)

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.

K082001DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116BDiazyme LaboratoriesK912244UROTEST GPHIn Wha Pharmaceutical Co., Ltd.

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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