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FDA 510(k)

GLUCOSE REAGENT SET (GOD/TRINDER)

K-Number: K854335 · 1985-11-22

ApplicantSterling Diagnostics, Inc.
Decision Date1985-11-22
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT SET (GOD/TRINDER) is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-11-22 under 510(k) number K854335. 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 REAGENT SET (GOD/TRINDER)?

GLUCOSE REAGENT SET (GOD/TRINDER) is a medical device that received FDA 510(k) clearance on 1985-11-22. The listed applicant is Sterling Diagnostics, Inc.. The 510(k) number is K854335.

When did GLUCOSE REAGENT SET (GOD/TRINDER) receive FDA 510(k) clearance?

GLUCOSE REAGENT SET (GOD/TRINDER) received FDA 510(k) clearance on 1985-11-22, under 510(k) number K854335.

Who is the listed applicant for GLUCOSE REAGENT SET (GOD/TRINDER)?

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

What is the FDA product code for GLUCOSE REAGENT SET (GOD/TRINDER)?

The FDA product code for GLUCOSE REAGENT SET (GOD/TRINDER) is CGA.

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Other records listing Sterling Diagnostics, 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.

K921412MICROPROTEIN REAGENT SETK914609TRIGLYCERIDES REAGENT SETK914039SODIUM REAGENT SETK914040PHOSPHOLIPID REAGENT SETK862255LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)K861962VANILMANDELIC ACID (VMA) REAGENT SET

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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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