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FDA 510(k)

ENZYMATIC TRIGLYCERIDES #2000

K-Number: K832444 · 1983-08-31

ApplicantStanbio Laboratory
Decision Date1983-08-31
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC TRIGLYCERIDES #2000 is the device name listed in this FDA 510(k) record. The listed applicant is Stanbio Laboratory. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832444. 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 ENZYMATIC TRIGLYCERIDES #2000?

ENZYMATIC TRIGLYCERIDES #2000 is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Stanbio Laboratory. The 510(k) number is K832444.

When did ENZYMATIC TRIGLYCERIDES #2000 receive FDA 510(k) clearance?

ENZYMATIC TRIGLYCERIDES #2000 received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832444.

Who is the listed applicant for ENZYMATIC TRIGLYCERIDES #2000?

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

What is the FDA product code for ENZYMATIC TRIGLYCERIDES #2000?

The FDA product code for ENZYMATIC TRIGLYCERIDES #2000 is CDT.

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Other records listing Stanbio Laboratory as applicant

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K090093STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEMK081719STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEMK050266DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLORK050283CREATININE LIQUICOLORK042169STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZERK041155WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY

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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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