Cleared Traditional

K803050 - SPRAY, SYNTHETIC SMEAR (FDA 510(k) Clearance)

K803050 · Laboratory Products, Inc. · Pathology device
Dec 1980
Decision
28d
Days
Class 1
Risk

K803050 is an FDA 510(k) clearance for the SPRAY, SYNTHETIC SMEAR. This device is classified as a Sprays, Synthetic, Smear (Class I - General Controls, product code IFI).

Submitted by Laboratory Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1980, 28 days after receiving the submission on December 2, 1980.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number K803050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1980
Decision Date December 30, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code IFI — Sprays, Synthetic, Smear
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.4010