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FDA 510(k)

COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581

K-Number: K901414 · 1990-06-15

ApplicantHelena Laboratories
Decision Date1990-06-15
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1990-06-15 under 510(k) number K901414. 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 COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581?

COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 is a medical device that received FDA 510(k) clearance on 1990-06-15. The listed applicant is Helena Laboratories. The 510(k) number is K901414.

When did COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 receive FDA 510(k) clearance?

COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 received FDA 510(k) clearance on 1990-06-15, under 510(k) number K901414.

Who is the listed applicant for COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581?

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 COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581?

The FDA product code for COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 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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