Cleared Traditional

K903933 - DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 (FDA 510(k) Clearance)

K903933 · Baxter Healthcare Corp · Chemistry device

Oct 1990

Decision

38d

Days

Class 1

Risk

K903933 is an FDA 510(k) clearance for the DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2. This device is classified as a Multi-analyte Controls, All Kinds (assayed) (Class I - General Controls, product code JJY).

Submitted by Baxter Healthcare Corp (Miami, US). The FDA issued a Cleared decision on October 4, 1990, 38 days after receiving the submission on August 27, 1990.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number	K903933 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 1990
Decision Date	October 04, 1990
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class	Class I - General Controls
CFR Regulation	21 CFR 862.1660