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FDA 510(k)

ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)

K-Number: K902455 · 1990-07-24

ApplicantAnalytical Control Systems, Inc.
Decision Date1990-07-24
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Control Systems, Inc.. It received FDA 510(k) clearance on 1990-07-24 under 510(k) number K902455. 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 ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)?

ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) is a medical device that received FDA 510(k) clearance on 1990-07-24. The listed applicant is Analytical Control Systems, Inc.. The 510(k) number is K902455.

When did ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) receive FDA 510(k) clearance?

ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) received FDA 510(k) clearance on 1990-07-24, under 510(k) number K902455.

Who is the listed applicant for ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)?

The FDA 510(k) record lists Analytical Control Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)?

The FDA product code for ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB) is LCP.

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Other records listing Analytical Control Systems, Inc. as applicant

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Related Devices (Code: LCP)

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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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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