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FDA 510(k)

LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL

K-Number: K862185 · 1986-08-04

ApplicantBio-Rad
Decision Date1986-08-04
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1986-08-04 under 510(k) number K862185. 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 PEDIATRIC AND BILIRUBIN CONTROL?

LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL is a medical device that received FDA 510(k) clearance on 1986-08-04. The listed applicant is Bio-Rad. The 510(k) number is K862185.

When did LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL receive FDA 510(k) clearance?

LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL received FDA 510(k) clearance on 1986-08-04, under 510(k) number K862185.

Who is the listed applicant for LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL?

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 PEDIATRIC AND BILIRUBIN CONTROL?

The FDA product code for LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL is JJY.

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Other records listing Bio-Rad as applicant

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Related Devices (Code: JJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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