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FDA 510(k)

BLOOD SPECIMEN COLLECTION DEVICES

K-Number: K863491 · 1986-10-24

ApplicantMedelec Intl. Corp.
Decision Date1986-10-24
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BLOOD SPECIMEN COLLECTION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Medelec Intl. Corp.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K863491. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD SPECIMEN COLLECTION DEVICES?

BLOOD SPECIMEN COLLECTION DEVICES is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is Medelec Intl. Corp.. The 510(k) number is K863491.

When did BLOOD SPECIMEN COLLECTION DEVICES receive FDA 510(k) clearance?

BLOOD SPECIMEN COLLECTION DEVICES received FDA 510(k) clearance on 1986-10-24, under 510(k) number K863491.

Who is the listed applicant for BLOOD SPECIMEN COLLECTION DEVICES?

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

What is the FDA product code for BLOOD SPECIMEN COLLECTION DEVICES?

The FDA product code for BLOOD SPECIMEN COLLECTION DEVICES is JKA.

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Other records listing Medelec Intl. Corp. as applicant

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Related Devices (Code: JKA)

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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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