FDA 510(k)

HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51

K-Number: K980772 · 1998-04-27

Decision Date1998-04-27

Product CodeLBR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1998-04-27 under 510(k) number K980772. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51?

HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 is a medical device that received FDA 510(k) clearance on 1998-04-27. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K980772.

When did HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 receive FDA 510(k) clearance?

HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 received FDA 510(k) clearance on 1998-04-27, under 510(k) number K980772.

Who is the listed applicant for HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51?

The FDA product code for HDL-CHOLESTEROL PRECIPITATING REAGENT, CATALOGUE NUMBER 205-51 is LBR.

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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.