FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

K Number

Device Name

MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229

Manufacturer

SYVA CO., DADE BEHRING, INC.

Date Cleared

2001-05-15

(29 days)

Product Code

Regulation Number

N/A

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

Device Description

AI/ML Overview

Summary

Regulation Number and Section

N/A