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FDA 510(k)

ROYCO MODEL 371 SUPER DILUTOR

K-Number: K791644 · 1979-09-19

ApplicantRoyco Instruments
Decision Date1979-09-19
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROYCO MODEL 371 SUPER DILUTOR is the device name listed in this FDA 510(k) record. The listed applicant is Royco Instruments. It received FDA 510(k) clearance on 1979-09-19 under 510(k) number K791644. The device is classified under product code GKH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYCO MODEL 371 SUPER DILUTOR?

ROYCO MODEL 371 SUPER DILUTOR is a medical device that received FDA 510(k) clearance on 1979-09-19. The listed applicant is Royco Instruments. The 510(k) number is K791644.

When did ROYCO MODEL 371 SUPER DILUTOR receive FDA 510(k) clearance?

ROYCO MODEL 371 SUPER DILUTOR received FDA 510(k) clearance on 1979-09-19, under 510(k) number K791644.

Who is the listed applicant for ROYCO MODEL 371 SUPER DILUTOR?

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

What is the FDA product code for ROYCO MODEL 371 SUPER DILUTOR?

The FDA product code for ROYCO MODEL 371 SUPER DILUTOR is GKH.

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Other records listing Royco Instruments 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.

K800104ROYCO MODEL 951 CELL MIXERK791867ROYCO MODEL 921 CELL COUNTERK790442ISOTONIC DILUENT

Related Devices (Code: GKH)

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.

K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLCK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon Corp.K021150COULTER CELLPREPBeckman Coulter, Inc.K935953COULTER MULTI Q PREPCoulter Corp.K923530COULTER MULTI-Q-PREPCoulter Electronics, Inc.

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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