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FDA 510(k)

ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD

K-Number: K854366 · 1985-11-25

ApplicantAmerican Monitor Corp.
Decision Date1985-11-25
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1985-11-25 under 510(k) number K854366. 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 GPO-GRINDER METHOD?

ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD is a medical device that received FDA 510(k) clearance on 1985-11-25. The listed applicant is American Monitor Corp.. The 510(k) number is K854366.

When did ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD receive FDA 510(k) clearance?

ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD received FDA 510(k) clearance on 1985-11-25, under 510(k) number K854366.

Who is the listed applicant for ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD?

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

What is the FDA product code for ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD?

The FDA product code for ENZYMATIC TRIGLYCERIDES GPO-GRINDER METHOD is CDT.

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Other records listing American Monitor 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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