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FDA 510(k)

EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.

K-Number: K013342 · 2002-02-15

ApplicantChay Medical, LLC
Decision Date2002-02-15
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. is the device name listed in this FDA 510(k) record. The listed applicant is Chay Medical, LLC. It received FDA 510(k) clearance on 2002-02-15 under 510(k) number K013342. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.?

EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. is a medical device that received FDA 510(k) clearance on 2002-02-15. The listed applicant is Chay Medical, LLC. The 510(k) number is K013342.

When did EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. receive FDA 510(k) clearance?

EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. received FDA 510(k) clearance on 2002-02-15, under 510(k) number K013342.

Who is the listed applicant for EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.?

The FDA 510(k) record lists Chay Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC.?

The FDA product code for EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. is CGA.

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 Chay Medical, LLC 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.

K021781EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS

Related Devices (Code: CGA)

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.

K252488ABL90 FLEX PLUS SystemRadiometer Medicals ApsK210933YSI 2900C Biochemistry AnalyzerYsi, Inc.K220328EasyStat 300Medica CorporationK223179Cholestech LDX ™ SystemAlere San Diego, Inc.K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K223710i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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