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FDA 510(k)

TRIGLYCERIDES (LIPASE) REAGENT SET

K-Number: K761262 · 1976-12-29

ApplicantWorthington Biochemical Corp.
Decision Date1976-12-29
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES (LIPASE) REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Biochemical Corp.. It received FDA 510(k) clearance on 1976-12-29 under 510(k) number K761262. 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 TRIGLYCERIDES (LIPASE) REAGENT SET?

TRIGLYCERIDES (LIPASE) REAGENT SET is a medical device that received FDA 510(k) clearance on 1976-12-29. The listed applicant is Worthington Biochemical Corp.. The 510(k) number is K761262.

When did TRIGLYCERIDES (LIPASE) REAGENT SET receive FDA 510(k) clearance?

TRIGLYCERIDES (LIPASE) REAGENT SET received FDA 510(k) clearance on 1976-12-29, under 510(k) number K761262.

Who is the listed applicant for TRIGLYCERIDES (LIPASE) REAGENT SET?

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

What is the FDA product code for TRIGLYCERIDES (LIPASE) REAGENT SET?

The FDA product code for TRIGLYCERIDES (LIPASE) REAGENT SET is CDT.

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Other records listing Worthington Biochemical Corp. 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.

K780389HDL REAGENT SET FOR LIPOPROTEINSK780096LDH ISOENZYME CONTROL SERUMK772356LDH ISOENZYME COLUMN REAGENT SETK772025URIC ACID STD. FOR QUANT. URIC ACIDK771001STATZYME GLUCOSEK770831STATZYME URIC ACID REAGENT

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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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