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FDA 510(k)

ACCU-CHEK II

K-Number: K851456 · 1985-08-01

ApplicantBoehringer Mannheim Corp.
Decision Date1985-08-01
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK II is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1985-08-01 under 510(k) number K851456. 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 ACCU-CHEK II?

ACCU-CHEK II is a medical device that received FDA 510(k) clearance on 1985-08-01. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K851456.

When did ACCU-CHEK II receive FDA 510(k) clearance?

ACCU-CHEK II received FDA 510(k) clearance on 1985-08-01, under 510(k) number K851456.

Who is the listed applicant for ACCU-CHEK II?

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

What is the FDA product code for ACCU-CHEK II?

The FDA product code for ACCU-CHEK II is CGA.

Other records listing Boehringer Mannheim 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.

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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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