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FDA 510(k)

FEB TEST

K-Number: K830564 · 1983-03-29

ApplicantWako Chemicals USA, Inc.
Decision Date1983-03-29
Product CodeCFM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FEB TEST is the device name listed in this FDA 510(k) record. The listed applicant is Wako Chemicals USA, Inc.. It received FDA 510(k) clearance on 1983-03-29 under 510(k) number K830564. The device is classified under product code CFM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEB TEST?

FEB TEST is a medical device that received FDA 510(k) clearance on 1983-03-29. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K830564.

When did FEB TEST receive FDA 510(k) clearance?

FEB TEST received FDA 510(k) clearance on 1983-03-29, under 510(k) number K830564.

Who is the listed applicant for FEB TEST?

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

What is the FDA product code for FEB TEST?

The FDA product code for FEB TEST is CFM.

Other records listing Wako Chemicals USA, 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.

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTIONK080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATORK062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401K053131WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191

View all 123 devices →

Related Devices (Code: CFM)

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.

K984119WAKO L-TYPE FE, WAKO L-TYPE CALIBRATORWako Chemicals USA, Inc.K981581IRONAbbott LaboratoriesK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERCatachem, Inc.K913705ABBOTT QLUICKSTART IRON TEST, ITEM #5A29Em Diagnostic Systems, Inc.K912912SYNERMED SERUM IRON-600 REAGENT KITSynermed, Inc.K902918SYNERMED SERUM IRON REAGENT KITSynermed, 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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