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FDA 510(k)

ROCKET REFERENCE PLASMA, CAT NO. 5188

K-Number: K900019 · 1990-01-25

ApplicantHelena Laboratories
Decision Date1990-01-25
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROCKET REFERENCE PLASMA, CAT NO. 5188 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1990-01-25 under 510(k) number K900019. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCKET REFERENCE PLASMA, CAT NO. 5188?

ROCKET REFERENCE PLASMA, CAT NO. 5188 is a medical device that received FDA 510(k) clearance on 1990-01-25. The listed applicant is Helena Laboratories. The 510(k) number is K900019.

When did ROCKET REFERENCE PLASMA, CAT NO. 5188 receive FDA 510(k) clearance?

ROCKET REFERENCE PLASMA, CAT NO. 5188 received FDA 510(k) clearance on 1990-01-25, under 510(k) number K900019.

Who is the listed applicant for ROCKET REFERENCE PLASMA, CAT NO. 5188?

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 ROCKET REFERENCE PLASMA, CAT NO. 5188?

The FDA product code for ROCKET REFERENCE PLASMA, CAT NO. 5188 is GGN.

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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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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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