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FDA 510(k)

MICROELISA MINIREADER II

K-Number: K830200 · 1983-02-16

ApplicantDynatech Corp.
Decision Date1983-02-16
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MICROELISA MINIREADER II is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Corp.. It received FDA 510(k) clearance on 1983-02-16 under 510(k) number K830200. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROELISA MINIREADER II?

MICROELISA MINIREADER II is a medical device that received FDA 510(k) clearance on 1983-02-16. The listed applicant is Dynatech Corp.. The 510(k) number is K830200.

When did MICROELISA MINIREADER II receive FDA 510(k) clearance?

MICROELISA MINIREADER II received FDA 510(k) clearance on 1983-02-16, under 510(k) number K830200.

Who is the listed applicant for MICROELISA MINIREADER II?

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

What is the FDA product code for MICROELISA MINIREADER II?

The FDA product code for MICROELISA MINIREADER II is LBI.

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Other records listing Dynatech Corp. as applicant

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Related Devices (Code: LBI)

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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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