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FDA 510(k)

ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER

K-Number: K780946 · 1978-07-27

ApplicantHycel, Inc.
Decision Date1978-07-27
Product CodeJPJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1978-07-27 under 510(k) number K780946. The device is classified under product code JPJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER?

ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Hycel, Inc.. The 510(k) number is K780946.

When did ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER receive FDA 510(k) clearance?

ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER received FDA 510(k) clearance on 1978-07-27, under 510(k) number K780946.

Who is the listed applicant for ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER?

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

What is the FDA product code for ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER?

The FDA product code for ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER is JPJ.

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Other records listing Hycel, Inc. 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.

K802422HYCEL TRIGYCERIDE II TESTK790335HYCEL MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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Related Devices (Code: JPJ)

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.

K904675QBC SYSTEM MCHCBd Becton Dickinson Vacutainer Systems PreanalyticK761304JTB 700 HEMATOLOGY ANALYZERJ.T. Baker Chemical Co.

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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