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FDA 510(k)

SERALYZER TRIGLYCERIDES REAGENT STRIPS

K-Number: K832684 · 1983-10-04

ApplicantMiles Laboratories, Inc.
Decision Date1983-10-04
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERALYZER TRIGLYCERIDES REAGENT STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832684. 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 SERALYZER TRIGLYCERIDES REAGENT STRIPS?

SERALYZER TRIGLYCERIDES REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K832684.

When did SERALYZER TRIGLYCERIDES REAGENT STRIPS receive FDA 510(k) clearance?

SERALYZER TRIGLYCERIDES REAGENT STRIPS received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832684.

Who is the listed applicant for SERALYZER TRIGLYCERIDES REAGENT STRIPS?

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

What is the FDA product code for SERALYZER TRIGLYCERIDES REAGENT STRIPS?

The FDA product code for SERALYZER TRIGLYCERIDES REAGENT STRIPS is CDT.

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Other records listing Miles Laboratories, 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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