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FDA 510(k)

STRIPREADER MICROELISA SYSTEM

K-Number: K831643 · 1983-07-26

ApplicantOrganon Teknika Corp.
Decision Date1983-07-26
Product CodeLIB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STRIPREADER MICROELISA SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K831643. The device is classified under product code LIB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRIPREADER MICROELISA SYSTEM?

STRIPREADER MICROELISA SYSTEM is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Organon Teknika Corp.. The 510(k) number is K831643.

When did STRIPREADER MICROELISA SYSTEM receive FDA 510(k) clearance?

STRIPREADER MICROELISA SYSTEM received FDA 510(k) clearance on 1983-07-26, under 510(k) number K831643.

Who is the listed applicant for STRIPREADER MICROELISA SYSTEM?

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

What is the FDA product code for STRIPREADER MICROELISA SYSTEM?

The FDA product code for STRIPREADER MICROELISA SYSTEM is LIB.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: LIB)

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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