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FDA 510(k)

TRIGLYCERIDES REAGENT SET TAG-GK

K-Number: K823341 · 1982-12-22

ApplicantSterling Biochemical, Inc.
Decision Date1982-12-22
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES REAGENT SET TAG-GK is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Biochemical, Inc.. It received FDA 510(k) clearance on 1982-12-22 under 510(k) number K823341. 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 REAGENT SET TAG-GK?

TRIGLYCERIDES REAGENT SET TAG-GK is a medical device that received FDA 510(k) clearance on 1982-12-22. The listed applicant is Sterling Biochemical, Inc.. The 510(k) number is K823341.

When did TRIGLYCERIDES REAGENT SET TAG-GK receive FDA 510(k) clearance?

TRIGLYCERIDES REAGENT SET TAG-GK received FDA 510(k) clearance on 1982-12-22, under 510(k) number K823341.

Who is the listed applicant for TRIGLYCERIDES REAGENT SET TAG-GK?

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

What is the FDA product code for TRIGLYCERIDES REAGENT SET TAG-GK?

The FDA product code for TRIGLYCERIDES REAGENT SET TAG-GK is CDT.

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Other records listing Sterling Biochemical, 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.

K844998GLUCOSE(HEXOKINASE) REAGENT SETK844251ALT/GPT REAGENT SETK843332ALKALINE PHOSPHATASE REAGENT SETK842521AST/GOT REAGENT SET UV RATEK840064UREA NITROGEN REAGENT SETK834084HYDROXYBUTYRATE DEHYDROGENASE 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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