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FDA 510(k)

CHEM-STRATE TRIGLYCERIDE

K-Number: K792480 · 1979-12-27

ApplicantGeneral Diagnostics
Decision Date1979-12-27
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM-STRATE TRIGLYCERIDE is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1979-12-27 under 510(k) number K792480. 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 CHEM-STRATE TRIGLYCERIDE?

CHEM-STRATE TRIGLYCERIDE is a medical device that received FDA 510(k) clearance on 1979-12-27. The listed applicant is General Diagnostics. The 510(k) number is K792480.

When did CHEM-STRATE TRIGLYCERIDE receive FDA 510(k) clearance?

CHEM-STRATE TRIGLYCERIDE received FDA 510(k) clearance on 1979-12-27, under 510(k) number K792480.

Who is the listed applicant for CHEM-STRATE TRIGLYCERIDE?

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

What is the FDA product code for CHEM-STRATE TRIGLYCERIDE?

The FDA product code for CHEM-STRATE TRIGLYCERIDE is CDT.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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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

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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