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FDA 510(k)

SPUNCRIT

K-Number: K925863 · 1993-02-05

ApplicantbioMerieux, Inc.
Decision Date1993-02-05
Product CodeGKG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPUNCRIT is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 1993-02-05 under 510(k) number K925863. 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?

SPUNCRIT is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is bioMerieux, Inc.. The 510(k) number is K925863.

When did SPUNCRIT receive FDA 510(k) clearance?

SPUNCRIT received FDA 510(k) clearance on 1993-02-05, under 510(k) number K925863.

Who is the listed applicant for SPUNCRIT?

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

What is the FDA product code for SPUNCRIT?

The FDA product code for SPUNCRIT is GKG.

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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.

K961803SPUNCRIT (MODEL DRC-40)Micro Diagnostics Corp.K955795MULTI-CENTRIFUGENovonx, Inc.K930415MICROHEMATOCRIT ROTORFisher Scientific Co., LLCK920207HERMLE Z230HLabnet Intl., Inc.K920759CRITSPIN MICRO-HEMATOCRITStat-Spin TechnologiesK913128HEMATASTAT C-70BSeparation Technology, 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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