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FDA 510(k)

IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY

K-Number: K813525 · 1981-12-31

ApplicantMicromedic Systems
Decision Date1981-12-31
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813525. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY?

IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Micromedic Systems. The 510(k) number is K813525.

When did IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY receive FDA 510(k) clearance?

IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813525.

Who is the listed applicant for IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY?

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

What is the FDA product code for IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY?

The FDA product code for IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY is JLW.

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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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