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FDA 510(k)

LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483

K-Number: K002196 · 2000-08-07

ApplicantBio-Rad
Decision Date2000-08-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2000-08-07 under 510(k) number K002196. 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 FERTILITY CONTROL, MODELS 480, 481, 482, 483?

LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 is a medical device that received FDA 510(k) clearance on 2000-08-07. The listed applicant is Bio-Rad. The 510(k) number is K002196.

When did LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 receive FDA 510(k) clearance?

LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 received FDA 510(k) clearance on 2000-08-07, under 510(k) number K002196.

Who is the listed applicant for LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483?

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 FERTILITY CONTROL, MODELS 480, 481, 482, 483?

The FDA product code for LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 is JJY.

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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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