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FDA 510(k)

SPUNCRIT (MODEL DRC-40)

K-Number: K961803 · 1996-07-05

ApplicantMicro Diagnostics Corp.
Decision Date1996-07-05
Product CodeGKG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPUNCRIT (MODEL DRC-40) is the device name listed in this FDA 510(k) record. The listed applicant is Micro Diagnostics Corp.. It received FDA 510(k) clearance on 1996-07-05 under 510(k) number K961803. The device is classified under product code GKG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPUNCRIT (MODEL DRC-40)?

SPUNCRIT (MODEL DRC-40) is a medical device that received FDA 510(k) clearance on 1996-07-05. The listed applicant is Micro Diagnostics Corp.. The 510(k) number is K961803.

When did SPUNCRIT (MODEL DRC-40) receive FDA 510(k) clearance?

SPUNCRIT (MODEL DRC-40) received FDA 510(k) clearance on 1996-07-05, under 510(k) number K961803.

Who is the listed applicant for SPUNCRIT (MODEL DRC-40)?

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

What is the FDA product code for SPUNCRIT (MODEL DRC-40)?

The FDA product code for SPUNCRIT (MODEL DRC-40) is GKG.

Related Clinical Trials

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Related Devices (Code: GKG)

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.

K955795MULTI-CENTRIFUGENovonx, Inc.K930415MICROHEMATOCRIT ROTORFisher Scientific Co., LLCK925863SPUNCRITbioMerieux, Inc.K920207HERMLE Z230HLabnet Intl., Inc.K920759CRITSPIN MICRO-HEMATOCRITStat-Spin TechnologiesK913128HEMATASTAT C-70BSeparation Technology, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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