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FDA 510(k)

LYPHOCHEK DRUG FREE SERUM(HUMAN)

K-Number: K852414 · 1985-07-24

ApplicantBio-Rad
Decision Date1985-07-24
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK DRUG FREE SERUM(HUMAN) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1985-07-24 under 510(k) number K852414. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK DRUG FREE SERUM(HUMAN)?

LYPHOCHEK DRUG FREE SERUM(HUMAN) is a medical device that received FDA 510(k) clearance on 1985-07-24. The listed applicant is Bio-Rad. The 510(k) number is K852414.

When did LYPHOCHEK DRUG FREE SERUM(HUMAN) receive FDA 510(k) clearance?

LYPHOCHEK DRUG FREE SERUM(HUMAN) received FDA 510(k) clearance on 1985-07-24, under 510(k) number K852414.

Who is the listed applicant for LYPHOCHEK DRUG FREE SERUM(HUMAN)?

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

What is the FDA product code for LYPHOCHEK DRUG FREE SERUM(HUMAN)?

The FDA product code for LYPHOCHEK DRUG FREE SERUM(HUMAN) is DIF.

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Related Devices (Code: DIF)

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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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