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FDA 510(k)

ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD

K-Number: K871301 · 1987-04-22

ApplicantAmerican Monitor Corp.
Decision Date1987-04-22
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC TRIGLYCERIDES GPO-TRINDER 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 1987-04-22 under 510(k) number K871301. 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-TRINDER METHOD?

ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD is a medical device that received FDA 510(k) clearance on 1987-04-22. The listed applicant is American Monitor Corp.. The 510(k) number is K871301.

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

ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD received FDA 510(k) clearance on 1987-04-22, under 510(k) number K871301.

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

The FDA product code for ENZYMATIC TRIGLYCERIDES GPO-TRINDER 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.

K895999PHOSPHORUSK896000ASPARTATE AMINOTRANFERASE (AST)K896001ALANINE 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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