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FDA 510(k)

MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C

K-Number: K001891 · 2000-07-12

ApplicantBio/Data Corp.
Decision Date2000-07-12
Product CodeGKP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 2000-07-12 under 510(k) number K001891. The device is classified under product code GKP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C?

MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C is a medical device that received FDA 510(k) clearance on 2000-07-12. The listed applicant is Bio/Data Corp.. The 510(k) number is K001891.

When did MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C receive FDA 510(k) clearance?

MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C received FDA 510(k) clearance on 2000-07-12, under 510(k) number K001891.

Who is the listed applicant for MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C?

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

What is the FDA product code for MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C?

The FDA product code for MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C is GKP.

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Other records listing Bio/Data Corp. as applicant

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Related Devices (Code: GKP)

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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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