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FDA 510(k)

AUTOMATIC ELISA READER

K-Number: K811111 · 1981-05-08

ApplicantArtek Systems Corp.
Decision Date1981-05-08
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOMATIC ELISA READER is the device name listed in this FDA 510(k) record. The listed applicant is Artek Systems Corp.. It received FDA 510(k) clearance on 1981-05-08 under 510(k) number K811111. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATIC ELISA READER?

AUTOMATIC ELISA READER is a medical device that received FDA 510(k) clearance on 1981-05-08. The listed applicant is Artek Systems Corp.. The 510(k) number is K811111.

When did AUTOMATIC ELISA READER receive FDA 510(k) clearance?

AUTOMATIC ELISA READER received FDA 510(k) clearance on 1981-05-08, under 510(k) number K811111.

Who is the listed applicant for AUTOMATIC ELISA READER?

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

What is the FDA product code for AUTOMATIC ELISA READER?

The FDA product code for AUTOMATIC ELISA READER is JJQ.

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Related Devices (Code: JJQ)

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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