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FDA 510(k)

ACCUCHEK BG.

K-Number: K821091 · 1982-05-14

ApplicantBiodynamics Corp.
Decision Date1982-05-14
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUCHEK BG. is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1982-05-14 under 510(k) number K821091. 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 ACCUCHEK BG.?

ACCUCHEK BG. is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Biodynamics Corp.. The 510(k) number is K821091.

When did ACCUCHEK BG. receive FDA 510(k) clearance?

ACCUCHEK BG. received FDA 510(k) clearance on 1982-05-14, under 510(k) number K821091.

Who is the listed applicant for ACCUCHEK BG.?

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

What is the FDA product code for ACCUCHEK BG.?

The FDA product code for ACCUCHEK BG. is CGA.

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Other records listing Biodynamics 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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUS

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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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