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FDA 510(k)

LIPASE HYDROLYSIS/GLYCEROL KINASE

K-Number: K832871 · 1983-10-14

ApplicantPointe Scientific, Inc.,
Decision Date1983-10-14
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE HYDROLYSIS/GLYCEROL KINASE is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832871. 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 LIPASE HYDROLYSIS/GLYCEROL KINASE?

LIPASE HYDROLYSIS/GLYCEROL KINASE is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K832871.

When did LIPASE HYDROLYSIS/GLYCEROL KINASE receive FDA 510(k) clearance?

LIPASE HYDROLYSIS/GLYCEROL KINASE received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832871.

Who is the listed applicant for LIPASE HYDROLYSIS/GLYCEROL KINASE?

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

What is the FDA product code for LIPASE HYDROLYSIS/GLYCEROL KINASE?

The FDA product code for LIPASE HYDROLYSIS/GLYCEROL KINASE is CDT.

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Other records listing Pointe Scientific, 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.

K070757MICROPROTEIN REAGENT SETK062118POINTE 360K070251CARBON DIOXIDE LIQUID STABLE REAGENTK070207MULTI-ANALYTE CHEMISTRY CALIBRATORK070504AMMONIA/ALCOHOL CONTROL SETK061377APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS

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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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