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FDA 510(k)

TRIGLYCERIDE REAGENT SET

K-Number: K770993 · 1977-09-02

ApplicantMacomb Chemical Co.
Decision Date1977-09-02
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDE REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1977-09-02 under 510(k) number K770993. 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 TRIGLYCERIDE REAGENT SET?

TRIGLYCERIDE REAGENT SET is a medical device that received FDA 510(k) clearance on 1977-09-02. The listed applicant is Macomb Chemical Co.. The 510(k) number is K770993.

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

TRIGLYCERIDE REAGENT SET received FDA 510(k) clearance on 1977-09-02, under 510(k) number K770993.

Who is the listed applicant for TRIGLYCERIDE REAGENT SET?

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

What is the FDA product code for TRIGLYCERIDE REAGENT SET?

The FDA product code for TRIGLYCERIDE REAGENT SET is CDT.

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Other records listing Macomb Chemical Co. 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.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO

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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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