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FDA 510(k)

REFRIG. CENTRIFUGE (DRUCKER MODEL)

K-Number: K800381 · 1980-03-19

ApplicantCoulter Electronics, Inc.
Decision Date1980-03-19
Product CodeJQC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REFRIG. CENTRIFUGE (DRUCKER MODEL) is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1980-03-19 under 510(k) number K800381. The device is classified under product code JQC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REFRIG. CENTRIFUGE (DRUCKER MODEL)?

REFRIG. CENTRIFUGE (DRUCKER MODEL) is a medical device that received FDA 510(k) clearance on 1980-03-19. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K800381.

When did REFRIG. CENTRIFUGE (DRUCKER MODEL) receive FDA 510(k) clearance?

REFRIG. CENTRIFUGE (DRUCKER MODEL) received FDA 510(k) clearance on 1980-03-19, under 510(k) number K800381.

Who is the listed applicant for REFRIG. CENTRIFUGE (DRUCKER MODEL)?

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

What is the FDA product code for REFRIG. CENTRIFUGE (DRUCKER MODEL)?

The FDA product code for REFRIG. CENTRIFUGE (DRUCKER MODEL) is JQC.

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Other records listing Coulter Electronics, Inc. as applicant

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Related Devices (Code: JQC)

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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