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FDA 510(k)

AUTO HDL CHOLESTEROL CALIBRATOR

K-Number: K970933 · 1997-05-23

ApplicantPointe Scientific, Inc.,
Decision Date1997-05-23
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTO HDL CHOLESTEROL CALIBRATOR 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 1997-05-23 under 510(k) number K970933. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO HDL CHOLESTEROL CALIBRATOR?

AUTO HDL CHOLESTEROL CALIBRATOR is a medical device that received FDA 510(k) clearance on 1997-05-23. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K970933.

When did AUTO HDL CHOLESTEROL CALIBRATOR receive FDA 510(k) clearance?

AUTO HDL CHOLESTEROL CALIBRATOR received FDA 510(k) clearance on 1997-05-23, under 510(k) number K970933.

Who is the listed applicant for AUTO HDL CHOLESTEROL CALIBRATOR?

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 AUTO HDL CHOLESTEROL CALIBRATOR?

The FDA product code for AUTO HDL CHOLESTEROL CALIBRATOR is JIS.

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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: JIS)

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.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

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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