FDA 510(k)

AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)

K-Number: K912024 · 1991-07-19

Decision Date1991-07-19

Product CodeJJE

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) 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 1991-07-19 under 510(k) number K912024. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)?

AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) is a medical device that received FDA 510(k) clearance on 1991-07-19. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K912024.

When did AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) receive FDA 510(k) clearance?

AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) received FDA 510(k) clearance on 1991-07-19, under 510(k) number K912024.

Who is the listed applicant for AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)?

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 AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R)?

The FDA product code for AUTOMATED BIOCHEMICAL ANALYZER (WAK0-20R & 30R) is JJE.

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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: JJE)

K183375Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride ElectrodeHoriba, Ltd.K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc.K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare Diagnostics K110035INDIKOThermofisher Scientific OY K073370TC MATRIX CLINICAL CHEMISTRY ANALYZERTeco Diagnostics

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.