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FDA 510(k)

TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL

K-Number: K873049 · 1987-08-28

ApplicantBoehringer Mannheim Corp.
Decision Date1987-08-28
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL 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 1987-08-28 under 510(k) number K873049. 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 GPO WITHOUT FREE GLYCEROL?

TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL is a medical device that received FDA 510(k) clearance on 1987-08-28. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K873049.

When did TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL receive FDA 510(k) clearance?

TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL received FDA 510(k) clearance on 1987-08-28, under 510(k) number K873049.

Who is the listed applicant for TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL?

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 TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL?

The FDA product code for TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL is CDT.

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Other records listing Boehringer Mannheim 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.

K984326ELECYS IGE ASSAYK983047ACCU-CHEK HQ SYSTEMK984419ELECSYS IGE CALCHECKK984425MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATORK984372ELECSYS CALCHECK TROPONIN TK984105ELECSYS TROPONIN T STAT TEST

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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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