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FDA 510(k)

ELISA PLUS SYSTEM

K-Number: K830212 · 1983-04-05

ApplicantWilliam-Palmer Industries, Inc.
Decision Date1983-04-05
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELISA PLUS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is William-Palmer Industries, Inc.. It received FDA 510(k) clearance on 1983-04-05 under 510(k) number K830212. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELISA PLUS SYSTEM?

ELISA PLUS SYSTEM is a medical device that received FDA 510(k) clearance on 1983-04-05. The listed applicant is William-Palmer Industries, Inc.. The 510(k) number is K830212.

When did ELISA PLUS SYSTEM receive FDA 510(k) clearance?

ELISA PLUS SYSTEM received FDA 510(k) clearance on 1983-04-05, under 510(k) number K830212.

Who is the listed applicant for ELISA PLUS SYSTEM?

The FDA 510(k) record lists William-Palmer Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELISA PLUS SYSTEM?

The FDA product code for ELISA PLUS SYSTEM is JJE.

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Related Devices (Code: JJE)

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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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