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FDA 510(k)

LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT

K-Number: K897150 · 1990-02-26

ApplicantToyo Jozo Co., Ltd.
Decision Date1990-02-26
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Toyo Jozo Co., Ltd.. It received FDA 510(k) clearance on 1990-02-26 under 510(k) number K897150. The device is classified under product code CHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT?

LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is Toyo Jozo Co., Ltd.. The 510(k) number is K897150.

When did LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT receive FDA 510(k) clearance?

LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT received FDA 510(k) clearance on 1990-02-26, under 510(k) number K897150.

Who is the listed applicant for LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT?

The FDA 510(k) record lists Toyo Jozo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT?

The FDA product code for LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT is CHI.

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Related Devices (Code: CHI)

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.

K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc.K961179SENTINEL LIPASE LIQUID MODEL 17.401BEqual Diagnostics, Inc.K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSBeckman Instruments, Inc.K952647IL TEST LIPASEInstrumentation Laboratory COK952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical ProductsK941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma 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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