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FDA 510(k)

REAGENT SET, CHOLESTEROL

K-Number: K781721 · 1978-11-03

ApplicantMedical Analysis Systems, Inc.
Decision Date1978-11-03
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SET, CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1978-11-03 under 510(k) number K781721. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT SET, CHOLESTEROL?

REAGENT SET, CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1978-11-03. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K781721.

When did REAGENT SET, CHOLESTEROL receive FDA 510(k) clearance?

REAGENT SET, CHOLESTEROL received FDA 510(k) clearance on 1978-11-03, under 510(k) number K781721.

Who is the listed applicant for REAGENT SET, CHOLESTEROL?

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

What is the FDA product code for REAGENT SET, CHOLESTEROL?

The FDA product code for REAGENT SET, CHOLESTEROL is CHH.

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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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