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FDA 510(k)

GLUCOSE STANDARD

K-Number: K810091 · 1981-01-26

ApplicantAnco Medical Reagents & Assoc.
Decision Date1981-01-26
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE 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 1981-01-26 under 510(k) number K810091. 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 GLUCOSE STANDARD?

GLUCOSE STANDARD is a medical device that received FDA 510(k) clearance on 1981-01-26. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K810091.

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

GLUCOSE STANDARD received FDA 510(k) clearance on 1981-01-26, under 510(k) number K810091.

Who is the listed applicant for GLUCOSE 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 GLUCOSE STANDARD?

The FDA product code for GLUCOSE 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.

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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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