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FDA 510(k)

MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL

K-Number: K881259 · 1988-10-12

ApplicantTriton Biosciences, Inc.
Decision Date1988-10-12
Product CodeLYE
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL is the device name listed in this FDA 510(k) record. The listed applicant is Triton Biosciences, Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K881259. The device is classified under product code LYE. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL?

MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is Triton Biosciences, Inc.. The 510(k) number is K881259.

When did MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL receive FDA 510(k) clearance?

MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL received FDA 510(k) clearance on 1988-10-12, under 510(k) number K881259.

Who is the listed applicant for MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL?

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

What is the FDA product code for MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL?

The FDA product code for MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL is LYE.

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Related Devices (Code: LYE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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