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FDA 510(k)

ACCU-CHEK A1C HEMOGLOBIN TEST

K-Number: K974491 · 1998-05-13

ApplicantBoehringer Mannheim Corp.
Decision Date1998-05-13
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK A1C HEMOGLOBIN TEST 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 1998-05-13 under 510(k) number K974491. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU-CHEK A1C HEMOGLOBIN TEST?

ACCU-CHEK A1C HEMOGLOBIN TEST is a medical device that received FDA 510(k) clearance on 1998-05-13. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K974491.

When did ACCU-CHEK A1C HEMOGLOBIN TEST receive FDA 510(k) clearance?

ACCU-CHEK A1C HEMOGLOBIN TEST received FDA 510(k) clearance on 1998-05-13, under 510(k) number K974491.

Who is the listed applicant for ACCU-CHEK A1C HEMOGLOBIN TEST?

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 A1C HEMOGLOBIN TEST?

The FDA product code for ACCU-CHEK A1C HEMOGLOBIN TEST is LCP.

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Related Devices (Code: LCP)

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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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