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FDA 510(k)

ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED

K-Number: K911777 · 1991-08-22

ApplicantHelena Laboratories
Decision Date1991-08-22
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1991-08-22 under 510(k) number K911777. 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, MODIFIED?

ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED is a medical device that received FDA 510(k) clearance on 1991-08-22. The listed applicant is Helena Laboratories. The 510(k) number is K911777.

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

ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED received FDA 510(k) clearance on 1991-08-22, under 510(k) number K911777.

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

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, MODIFIED?

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

K131479V8 SP NORMAL CONTROL, ABNORMAL CONTROLK100103SPECIALTY ASSAYED CONTROL-2K061991PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACAK061069SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458K061014ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LPK050053HEMORAM/AGGRAM ANALYZER

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Related Devices (Code: GGN)

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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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