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FDA 510(k)

GLUCOSE AUTO& STAT GA-1120

K-Number: K843003 · 1984-09-28

ApplicantKyoto Diagnostics, Inc.
Decision Date1984-09-28
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE AUTO& STAT GA-1120 is the device name listed in this FDA 510(k) record. The listed applicant is Kyoto Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-09-28 under 510(k) number K843003. 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 GLUCOSE AUTO& STAT GA-1120?

GLUCOSE AUTO& STAT GA-1120 is a medical device that received FDA 510(k) clearance on 1984-09-28. The listed applicant is Kyoto Diagnostics, Inc.. The 510(k) number is K843003.

When did GLUCOSE AUTO& STAT GA-1120 receive FDA 510(k) clearance?

GLUCOSE AUTO& STAT GA-1120 received FDA 510(k) clearance on 1984-09-28, under 510(k) number K843003.

Who is the listed applicant for GLUCOSE AUTO& STAT GA-1120?

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

What is the FDA product code for GLUCOSE AUTO& STAT GA-1120?

The FDA product code for GLUCOSE AUTO& STAT GA-1120 is CGA.

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Other records listing Kyoto Diagnostics, Inc. as applicant

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K861733ADDITIONAL KYOTEST URINE TEST REAGENT STRIPSK842750OSMOTIC PRESSURE AUTO & STAT OM-6010K842168ATAGO URINE SPECIFIC GRAVITY & SERUMK841714KYOTEST 2V, URINE TEST REAGENT STRIPK841715KYOTEST UK URINE TEST REAGENT STRIPK841713KYOTEST UG URINE TEST REAGENT STRIP

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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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