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FDA 510(k)

GENERIC BLOOD GLUCOSE TEST STRIP

K-Number: K001092 · 2000-07-26

ApplicantInbios Intl., Inc.
Decision Date2000-07-26
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GENERIC BLOOD GLUCOSE TEST STRIP is the device name listed in this FDA 510(k) record. The listed applicant is Inbios Intl., Inc.. It received FDA 510(k) clearance on 2000-07-26 under 510(k) number K001092. 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 GENERIC BLOOD GLUCOSE TEST STRIP?

GENERIC BLOOD GLUCOSE TEST STRIP is a medical device that received FDA 510(k) clearance on 2000-07-26. The listed applicant is Inbios Intl., Inc.. The 510(k) number is K001092.

When did GENERIC BLOOD GLUCOSE TEST STRIP receive FDA 510(k) clearance?

GENERIC BLOOD GLUCOSE TEST STRIP received FDA 510(k) clearance on 2000-07-26, under 510(k) number K001092.

Who is the listed applicant for GENERIC BLOOD GLUCOSE TEST STRIP?

The FDA 510(k) record lists Inbios Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERIC BLOOD GLUCOSE TEST STRIP?

The FDA product code for GENERIC BLOOD GLUCOSE TEST STRIP is CGA.

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Other records listing Inbios Intl., 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.

K041817WEST NILE DETECT IGM ELISAK023483KALAZAR DETECTK992695INSURE PRO TESTK991515INSURE PREGNANCY TEST

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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