FDA 510(k)

QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL

K-Number: K872078 · 1987-06-18

ApplicantSolomon Park Research Laboratories

Decision Date1987-06-18

Product CodeDER

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Solomon Park Research Laboratories. It received FDA 510(k) clearance on 1987-06-18 under 510(k) number K872078. The device is classified under product code DER. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL?

QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL is a medical device that received FDA 510(k) clearance on 1987-06-18. The listed applicant is Solomon Park Research Laboratories. The 510(k) number is K872078.

When did QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL receive FDA 510(k) clearance?

QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL received FDA 510(k) clearance on 1987-06-18, under 510(k) number K872078.

Who is the listed applicant for QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL?

The FDA 510(k) record lists Solomon Park Research Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL?

The FDA product code for QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL is DER.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.