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FDA 510(k)

REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1

K-Number: K760195 · 1976-08-03

ApplicantCoulter Electronics, Inc.
Decision Date1976-08-03
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1976-08-03 under 510(k) number K760195. 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 REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1?

REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 is a medical device that received FDA 510(k) clearance on 1976-08-03. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K760195.

When did REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 receive FDA 510(k) clearance?

REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 received FDA 510(k) clearance on 1976-08-03, under 510(k) number K760195.

Who is the listed applicant for REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1?

The FDA 510(k) record lists Coulter Electronics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1?

The FDA product code for REAGENT, TRIGLY. C-ZYME NDC#12739-0017-1 is CDT.

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Other records listing Coulter Electronics, Inc. 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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