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FDA 510(k)

ALKALINE PHOSPHATASE REAGENT SET

K-Number: K812837 · 1982-01-29

ApplicantAnco Medical Reagents & Assoc.
Decision Date1982-01-29
Product CodeCJL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALKALINE PHOSPHATASE REAGENT SET 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 1982-01-29 under 510(k) number K812837. The device is classified under product code CJL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALKALINE PHOSPHATASE REAGENT SET?

ALKALINE PHOSPHATASE REAGENT SET is a medical device that received FDA 510(k) clearance on 1982-01-29. The listed applicant is Anco Medical Reagents & Assoc.. The 510(k) number is K812837.

When did ALKALINE PHOSPHATASE REAGENT SET receive FDA 510(k) clearance?

ALKALINE PHOSPHATASE REAGENT SET received FDA 510(k) clearance on 1982-01-29, under 510(k) number K812837.

Who is the listed applicant for ALKALINE PHOSPHATASE REAGENT SET?

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 ALKALINE PHOSPHATASE REAGENT SET?

The FDA product code for ALKALINE PHOSPHATASE REAGENT SET is CJL.

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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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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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