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FDA 510(k)

GLYCEROL SUBSTRATE

K-Number: K771905 · 1977-12-06

ApplicantSimmler & Son, Inc.
Decision Date1977-12-06
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLYCEROL SUBSTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Simmler & Son, Inc.. It received FDA 510(k) clearance on 1977-12-06 under 510(k) number K771905. 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 GLYCEROL SUBSTRATE?

GLYCEROL SUBSTRATE is a medical device that received FDA 510(k) clearance on 1977-12-06. The listed applicant is Simmler & Son, Inc.. The 510(k) number is K771905.

When did GLYCEROL SUBSTRATE receive FDA 510(k) clearance?

GLYCEROL SUBSTRATE received FDA 510(k) clearance on 1977-12-06, under 510(k) number K771905.

Who is the listed applicant for GLYCEROL SUBSTRATE?

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

What is the FDA product code for GLYCEROL SUBSTRATE?

The FDA product code for GLYCEROL SUBSTRATE is CDT.

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Other records listing Simmler & Son, Inc. 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.

K780817GLOBIN-TERGEK771903LIPASEK771906PHOSPHATEK771904GLYCEROL KINASEK761086REAGENTSK760476REAGENT, LACTATE DEHYDROGENASE

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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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