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FDA 510(k)

SERI-SEP SERUM/PLASMA ISLOLATOR

K-Number: K781629 · 1978-10-27

ApplicantWako Intl., Inc.
Decision Date1978-10-27
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERI-SEP SERUM/PLASMA ISLOLATOR is the device name listed in this FDA 510(k) record. The listed applicant is Wako Intl., Inc.. It received FDA 510(k) clearance on 1978-10-27 under 510(k) number K781629. 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 SERI-SEP SERUM/PLASMA ISLOLATOR?

SERI-SEP SERUM/PLASMA ISLOLATOR is a medical device that received FDA 510(k) clearance on 1978-10-27. The listed applicant is Wako Intl., Inc.. The 510(k) number is K781629.

When did SERI-SEP SERUM/PLASMA ISLOLATOR receive FDA 510(k) clearance?

SERI-SEP SERUM/PLASMA ISLOLATOR received FDA 510(k) clearance on 1978-10-27, under 510(k) number K781629.

Who is the listed applicant for SERI-SEP SERUM/PLASMA ISLOLATOR?

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

What is the FDA product code for SERI-SEP SERUM/PLASMA ISLOLATOR?

The FDA product code for SERI-SEP SERUM/PLASMA ISLOLATOR is JKA.

Related Clinical Trials

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.

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Other records listing Wako Intl., 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.

K790768WAKO CHOLESTEROL TESTK781899UREA NITROGEN TESTK781342GLUCOSE TEST

Related Devices (Code: JKA)

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.

K262215Profoject™ Safety Sliding Blood Collection SetCMT Health PTE., Ltd.K252899Female Culture Device; Male Culture Device; Transfer Device; Access DeviceZhejiang Kindly Medical Device Co., Ltd.K260128BD Preset™ and BD A-Line™ Arterial Blood Collection SyringesBecton, Dickinson and CompanyK252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and CompanyK252506BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached HolderBecton, Dickinson and CompanyK252040BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection TubesBecton, Dickinson and Company

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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