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FDA 510(k)

WAKO(TM) AUTOKIT AMYLASE

K-Number: K883059 · 1988-08-30

ApplicantWako Chemicals USA, Inc.
Decision Date1988-08-30
Product CodeCJA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WAKO(TM) AUTOKIT AMYLASE 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 1988-08-30 under 510(k) number K883059. The device is classified under product code CJA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAKO(TM) AUTOKIT AMYLASE?

WAKO(TM) AUTOKIT AMYLASE is a medical device that received FDA 510(k) clearance on 1988-08-30. The listed applicant is Wako Chemicals USA, Inc.. The 510(k) number is K883059.

When did WAKO(TM) AUTOKIT AMYLASE receive FDA 510(k) clearance?

WAKO(TM) AUTOKIT AMYLASE received FDA 510(k) clearance on 1988-08-30, under 510(k) number K883059.

Who is the listed applicant for WAKO(TM) AUTOKIT AMYLASE?

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(TM) AUTOKIT AMYLASE?

The FDA product code for WAKO(TM) AUTOKIT AMYLASE is CJA.

Related Clinical Trials

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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: CJA)

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.

K895555MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)Hichem DiagnosticsK884226AMYLASE REAGENT KIT FOR ASTRA SYSTEMSA-Kem, Inc.K873520PARAMAX AMYLASE REAGENTBaxter Healthcare CorpK862640AMYLASE LTSElectro-Nucleonics Laboratories, Inc.K863052ALPHA AMYLASEJ. D. Assoc.K860530AMYLASE REAGENT SET (MODIFIED CARAWAY)Sterling Diagnostics, 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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