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FDA 510(k)

STATZYME GLUCOSE

K-Number: K771001 · 1977-07-11

ApplicantWorthington Biochemical Corp.
Decision Date1977-07-11
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATZYME GLUCOSE is the device name listed in this FDA 510(k) record. The listed applicant is Worthington Biochemical Corp.. It received FDA 510(k) clearance on 1977-07-11 under 510(k) number K771001. 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 STATZYME GLUCOSE?

STATZYME GLUCOSE is a medical device that received FDA 510(k) clearance on 1977-07-11. The listed applicant is Worthington Biochemical Corp.. The 510(k) number is K771001.

When did STATZYME GLUCOSE receive FDA 510(k) clearance?

STATZYME GLUCOSE received FDA 510(k) clearance on 1977-07-11, under 510(k) number K771001.

Who is the listed applicant for STATZYME GLUCOSE?

The FDA 510(k) record lists Worthington Biochemical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATZYME GLUCOSE?

The FDA product code for STATZYME GLUCOSE is CGA.

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Other records listing Worthington Biochemical Corp. 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.

K780389HDL REAGENT SET FOR LIPOPROTEINSK780096LDH ISOENZYME CONTROL SERUMK772356LDH ISOENZYME COLUMN REAGENT SETK772025URIC ACID STD. FOR QUANT. URIC ACIDK771143INORGANIC PHOSPHORUS STANDARDSK770831STATZYME URIC ACID REAGENT

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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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