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FDA 510(k)

CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC

K-Number: K790556 · 1979-05-07

ApplicantCalbiochem-Behring Corp.
Decision Date1979-05-07
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1979-05-07 under 510(k) number K790556. 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 CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC?

CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC is a medical device that received FDA 510(k) clearance on 1979-05-07. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K790556.

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

CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC received FDA 510(k) clearance on 1979-05-07, under 510(k) number K790556.

Who is the listed applicant for CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC?

The FDA product code for CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC 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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