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FDA 510(k)

TWIN TRIGLYCERIDES GPO/CHOLESTEROL

K-Number: K861793 · 1986-06-27

ApplicantBoehringer Mannheim Corp.
Decision Date1986-06-27
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TWIN TRIGLYCERIDES GPO/CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1986-06-27 under 510(k) number K861793. 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 TWIN TRIGLYCERIDES GPO/CHOLESTEROL?

TWIN TRIGLYCERIDES GPO/CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K861793.

When did TWIN TRIGLYCERIDES GPO/CHOLESTEROL receive FDA 510(k) clearance?

TWIN TRIGLYCERIDES GPO/CHOLESTEROL received FDA 510(k) clearance on 1986-06-27, under 510(k) number K861793.

Who is the listed applicant for TWIN TRIGLYCERIDES GPO/CHOLESTEROL?

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

What is the FDA product code for TWIN TRIGLYCERIDES GPO/CHOLESTEROL?

The FDA product code for TWIN TRIGLYCERIDES GPO/CHOLESTEROL is CDT.

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Other records listing Boehringer Mannheim Corp. as applicant

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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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