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FDA 510(k)

AXIOM STABLE II TRIGLYCERIDES TEST

K-Number: K842443 · 1984-09-13

ApplicantAxiom, Inc.
Decision Date1984-09-13
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AXIOM STABLE II TRIGLYCERIDES TEST is the device name listed in this FDA 510(k) record. The listed applicant is Axiom, Inc.. It received FDA 510(k) clearance on 1984-09-13 under 510(k) number K842443. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM STABLE II TRIGLYCERIDES TEST?

AXIOM STABLE II TRIGLYCERIDES TEST is a medical device that received FDA 510(k) clearance on 1984-09-13. The listed applicant is Axiom, Inc.. The 510(k) number is K842443.

When did AXIOM STABLE II TRIGLYCERIDES TEST receive FDA 510(k) clearance?

AXIOM STABLE II TRIGLYCERIDES TEST received FDA 510(k) clearance on 1984-09-13, under 510(k) number K842443.

Who is the listed applicant for AXIOM STABLE II TRIGLYCERIDES TEST?

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

What is the FDA product code for AXIOM STABLE II TRIGLYCERIDES TEST?

The FDA product code for AXIOM STABLE II TRIGLYCERIDES TEST is CDT.

Related Clinical Trials

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.

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Other records listing Axiom, 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.

K883887AXIOM ATRAUM WOUND DRAINSK842442AXIOM STABLE II URIC ACID TESTK842441AXIOM STABLE II CHOLESTEROL TEST

Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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