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FDA 510(k)

CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL

K-Number: K802142 · 1980-10-10

ApplicantAmerican Dade
Decision Date1980-10-10
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1980-10-10 under 510(k) number K802142. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL?

CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL is a medical device that received FDA 510(k) clearance on 1980-10-10. The listed applicant is American Dade. The 510(k) number is K802142.

When did CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL receive FDA 510(k) clearance?

CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802142.

Who is the listed applicant for CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL?

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

What is the FDA product code for CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL?

The FDA product code for CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL is JPK.

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Other records listing American Dade as applicant

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Related Devices (Code: JPK)

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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