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FDA 510(k)

GLUCOSE (TRINDER) CAT. # 220-32

K-Number: K875211 · 1988-04-18

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1988-04-18
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE (TRINDER) CAT. # 220-32 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K875211. 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 (TRINDER) CAT. # 220-32?

GLUCOSE (TRINDER) CAT. # 220-32 is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K875211.

When did GLUCOSE (TRINDER) CAT. # 220-32 receive FDA 510(k) clearance?

GLUCOSE (TRINDER) CAT. # 220-32 received FDA 510(k) clearance on 1988-04-18, under 510(k) number K875211.

Who is the listed applicant for GLUCOSE (TRINDER) CAT. # 220-32?

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

What is the FDA product code for GLUCOSE (TRINDER) CAT. # 220-32?

The FDA product code for GLUCOSE (TRINDER) CAT. # 220-32 is CGA.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) as applicant

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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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