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FDA 510(k)

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS

K-Number: K052525 · 2006-03-29

ApplicantDFI Co., Ltd.
Decision Date2006-03-29
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS is the device name listed in this FDA 510(k) record. The listed applicant is DFI Co., Ltd.. It received FDA 510(k) clearance on 2006-03-29 under 510(k) number K052525. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS?

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is DFI Co., Ltd.. The 510(k) number is K052525.

When did CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS receive FDA 510(k) clearance?

CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS received FDA 510(k) clearance on 2006-03-29, under 510(k) number K052525.

Who is the listed applicant for CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS?

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

What is the FDA product code for CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS?

The FDA product code for CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS is JIL.

Related Clinical Trials

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.

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Other records listing DFI Co., Ltd. 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.

K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsK171521DUS R-50S (Urine Chemistry system)K102188CYBOW READER, MODELS 300 & 720

Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

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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