Cleared Traditional

K915003 - EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) (FDA 510(k) Clearance)

K915003 · Syva Co. · Toxicology device

Nov 1991

Decision

22d

Days

Class 2

Risk

K915003 is an FDA 510(k) clearance for the EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH). This device is classified as a Calibrators, Drug Mixture (Class II - Special Controls, product code DKB).

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on November 29, 1991, 22 days after receiving the submission on November 7, 1991.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number	K915003 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 07, 1991
Decision Date	November 29, 1991
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Statement

Device Classification

Product Code	DKB — Calibrators, Drug Mixture
Device Class	Class II - Special Controls
CFR Regulation	21 CFR 862.3200