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FDA 510(k)

CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION

K-Number: K914946 · 1992-01-13

ApplicantHelena Laboratories
Decision Date1992-01-13
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1992-01-13 under 510(k) number K914946. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION?

CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION is a medical device that received FDA 510(k) clearance on 1992-01-13. The listed applicant is Helena Laboratories. The 510(k) number is K914946.

When did CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION receive FDA 510(k) clearance?

CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION received FDA 510(k) clearance on 1992-01-13, under 510(k) number K914946.

Who is the listed applicant for CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION?

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

What is the FDA product code for CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION?

The FDA product code for CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION is GKP.

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Other records listing Helena Laboratories as applicant

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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Related Devices (Code: GKP)

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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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