FDA 510(k)

WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET

K-Number: K020972 · 2002-09-09

Decision Date2002-09-09

Product CodeDHR

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET 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 2002-09-09 under 510(k) number K020972. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET?

WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET is a medical device that received FDA 510(k) clearance on 2002-09-09. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K020972.

When did WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET receive FDA 510(k) clearance?

WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET received FDA 510(k) clearance on 2002-09-09, under 510(k) number K020972.

Who is the listed applicant for WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET?

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 WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET?

The FDA product code for WAKO RF-HA (2), RF CALIBRATOR, RF CALIBRATOR SET is DHR.

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Other records listing Wako Chemicals USA, Inc. as applicant

K100464UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION K080125APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201 K080123APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201 K061775WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR K062368WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401 K053132WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791

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Related Devices (Code: DHR)

K192727K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)Kamiya Biomedical Company K190088QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA ReagentsInova Diagnostics, Inc.K182747EliA RF IgM ImmunoassayPhadia AB K162263Optilite Rheumatoid Factor KitThe Binding Site Group , Ltd.K160070Rheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd.K102673RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEMPhadia US, 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.