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FDA 510(k)

KAWASUMI LABORATORY BLOOD DRAWING KIT

K-Number: K001043 · 2000-05-19

ApplicantKawasumi Laboratories America, Inc.
Decision Date2000-05-19
Product CodeKSB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

KAWASUMI LABORATORY BLOOD DRAWING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories America, Inc.. It received FDA 510(k) clearance on 2000-05-19 under 510(k) number K001043. The device is classified under product code KSB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAWASUMI LABORATORY BLOOD DRAWING KIT?

KAWASUMI LABORATORY BLOOD DRAWING KIT is a medical device that received FDA 510(k) clearance on 2000-05-19. The listed applicant is Kawasumi Laboratories America, Inc.. The 510(k) number is K001043.

When did KAWASUMI LABORATORY BLOOD DRAWING KIT receive FDA 510(k) clearance?

KAWASUMI LABORATORY BLOOD DRAWING KIT received FDA 510(k) clearance on 2000-05-19, under 510(k) number K001043.

Who is the listed applicant for KAWASUMI LABORATORY BLOOD DRAWING KIT?

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

What is the FDA product code for KAWASUMI LABORATORY BLOOD DRAWING KIT?

The FDA product code for KAWASUMI LABORATORY BLOOD DRAWING KIT is KSB.

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Other records listing Kawasumi Laboratories America, Inc. as applicant

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.

K102890K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER)K030385IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTORK001423KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARYK001426KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTERK001424KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD

Related Devices (Code: KSB)

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.

K172957Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKawasumi Laboratories, Inc.K820447ALPHA PLASMA TRANSFER SETAlpha Therapeutic Corp.K802940SUPER-SPIKE TRANSFER SETGeneva Laboratories, Inc.K791130FLU-VEN TK-2Venospital, Inc.K791131FLU VEN TR-1Venospital, 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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