FDA 510(k)

LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563

K-Number: K022041 · 2002-07-16

Decision Date2002-07-16

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2002-07-16 under 510(k) number K022041. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563?

LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 is a medical device that received FDA 510(k) clearance on 2002-07-16. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K022041.

When did LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 receive FDA 510(k) clearance?

LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 received FDA 510(k) clearance on 2002-07-16, under 510(k) number K022041.

Who is the listed applicant for LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563?

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

What is the FDA product code for LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563?

The FDA product code for LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563 is JJY.

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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.