Cleared Traditional

K926095 - REFRACTROL-SP
(FDA 510(k) Clearance)

K926095 · Medical Specialties, Inc. · Chemistry

Jan 1993

Decision

55d

Days

Class 1

Risk

K926095 is an FDA 510(k) clearance for the REFRACTROL-SP. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX).

Submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on January 26, 1993, 55 days after receiving the submission on December 2, 1992.

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

Submission Details

510(k) Number	K926095 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 1992
Decision Date	January 26, 1993
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF