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FDA 510(k)

CH-60 PLUS WHOLE BLOOD PLATELET CONTROL

K-Number: K802141 · 1980-10-10

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

Device Summary

CH-60 PLUS WHOLE BLOOD PLATELET CONTROL 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 K802141. 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 CONTROL?

CH-60 PLUS WHOLE BLOOD PLATELET CONTROL 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 K802141.

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

CH-60 PLUS WHOLE BLOOD PLATELET CONTROL received FDA 510(k) clearance on 1980-10-10, under 510(k) number K802141.

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

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 CONTROL?

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

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Other records listing American Dade as applicant

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K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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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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