Cleared Traditional

K781143 - IMMUNOFLUORESCENCE TEST KIT (FDA 510(k) Clearance)

Aug 1978
Decision
35d
Days
Risk

K781143 is an FDA 510(k) clearance for the IMMUNOFLUORESCENCE TEST KIT..

Submitted by Microbiological Assoc. (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978, 35 days after receiving the submission on July 10, 1978.

This device falls under the Immunology FDA review panel.

Submission Details

510(k) Number K781143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1978
Decision Date August 14, 1978
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary

Device Classification

Product Code
Device Class