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FDA 510(k)

CHOLESTEROL STANDARD

K-Number: K810092 · 1981-02-02

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-02-02
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL STANDARD is the device name listed in this FDA 510(k) record. The listed applicant is Anco Medical Reagents & Assoc.. It received FDA 510(k) clearance on 1981-02-02 under 510(k) number K810092. 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 CHOLESTEROL STANDARD?

CHOLESTEROL STANDARD is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K810092.

When did CHOLESTEROL STANDARD receive FDA 510(k) clearance?

CHOLESTEROL STANDARD received FDA 510(k) clearance on 1981-02-02, under 510(k) number K810092.

Who is the listed applicant for CHOLESTEROL STANDARD?

The FDA 510(k) record lists Anco Medical Reagents & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL STANDARD?

The FDA product code for CHOLESTEROL STANDARD is JIS.

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Other records listing Anco Medical Reagents & Assoc. 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.

K842440SICKLE CELL STAT A/S HETEROZYGOUS-ERYTHK831871SICKLE-HEME A/S CONTROLS & A/A CONTROLK821658HEMOGLOBIN REAGENTK821526ACID PHOSPHATASE REAGENT SETK821102MEGNESIUM REAGENT KITK820951ENZYMATIC CHOLESTEROL KIT

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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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