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FDA 510(k)

TRIGLYCERIDES FOR SMA AND AAII

K-Number: K801226 · 1980-06-20

ApplicantReagents Applications, Inc.
Decision Date1980-06-20
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TRIGLYCERIDES FOR SMA AND AAII is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1980-06-20 under 510(k) number K801226. 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 FOR SMA AND AAII?

TRIGLYCERIDES FOR SMA AND AAII is a medical device that received FDA 510(k) clearance on 1980-06-20. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K801226.

When did TRIGLYCERIDES FOR SMA AND AAII receive FDA 510(k) clearance?

TRIGLYCERIDES FOR SMA AND AAII received FDA 510(k) clearance on 1980-06-20, under 510(k) number K801226.

Who is the listed applicant for TRIGLYCERIDES FOR SMA AND AAII?

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

What is the FDA product code for TRIGLYCERIDES FOR SMA AND AAII?

The FDA product code for TRIGLYCERIDES FOR SMA AND AAII is CDT.

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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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