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FDA 510(k)

AUTO AIC ANALYZER SYSTEM

K-Number: K833772 · 1984-01-18

ApplicantHelena Laboratories
Decision Date1984-01-18
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTO AIC ANALYZER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1984-01-18 under 510(k) number K833772. 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 AUTO AIC ANALYZER SYSTEM?

AUTO AIC ANALYZER SYSTEM is a medical device that received FDA 510(k) clearance on 1984-01-18. The listed applicant is Helena Laboratories. The 510(k) number is K833772.

When did AUTO AIC ANALYZER SYSTEM receive FDA 510(k) clearance?

AUTO AIC ANALYZER SYSTEM received FDA 510(k) clearance on 1984-01-18, under 510(k) number K833772.

Who is the listed applicant for AUTO AIC ANALYZER SYSTEM?

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

What is the FDA product code for AUTO AIC ANALYZER SYSTEM?

The FDA product code for AUTO AIC ANALYZER SYSTEM is LCP.

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Other records listing Helena Laboratories 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: 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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