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FDA 510(k)

HYCEL ROTOR-MIXER AND/OR MULTI

K-Number: K842746 · 1984-08-17

ApplicantR&D Systems, Inc.
Decision Date1984-08-17
Product CodeKSQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HYCEL ROTOR-MIXER AND/OR MULTI is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1984-08-17 under 510(k) number K842746. The device is classified under product code KSQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYCEL ROTOR-MIXER AND/OR MULTI?

HYCEL ROTOR-MIXER AND/OR MULTI is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is R&D Systems, Inc.. The 510(k) number is K842746.

When did HYCEL ROTOR-MIXER AND/OR MULTI receive FDA 510(k) clearance?

HYCEL ROTOR-MIXER AND/OR MULTI received FDA 510(k) clearance on 1984-08-17, under 510(k) number K842746.

Who is the listed applicant for HYCEL ROTOR-MIXER AND/OR MULTI?

The FDA 510(k) record lists R&D Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYCEL ROTOR-MIXER AND/OR MULTI?

The FDA product code for HYCEL ROTOR-MIXER AND/OR MULTI is KSQ.

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Other records listing R&D Systems, Inc. as applicant

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Related Devices (Code: KSQ)

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.

K820712SEPCOR UNIT COLLECTION MONITORSeparation Science Corp.K812533PLATELET AGITATORHelmer Labs, Inc.K810617MOBILE MATIC AUTOMATIC DONOR SCALELifeline Instruments, Inc.K802608HEMATIC BLOOD MIXERHelmer Labs, Inc.K800104ROYCO MODEL 951 CELL MIXERRoyco InstrumentsK780189PLATELET ROTATORTravenol Laboratories, S.A.

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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