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FDA 510(k)

HELENA RISTOCETIN

K-Number: K800432 · 1980-03-25

ApplicantHelena Laboratories
Decision Date1980-03-25
Product CodeJOZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HELENA RISTOCETIN is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K800432. The device is classified under product code JOZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HELENA RISTOCETIN?

HELENA RISTOCETIN is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Helena Laboratories. The 510(k) number is K800432.

When did HELENA RISTOCETIN receive FDA 510(k) clearance?

HELENA RISTOCETIN received FDA 510(k) clearance on 1980-03-25, under 510(k) number K800432.

Who is the listed applicant for HELENA RISTOCETIN?

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 HELENA RISTOCETIN?

The FDA product code for HELENA RISTOCETIN is JOZ.

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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: JOZ)

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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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