Cleared Traditional

K802741 - CENTRIFICHEM COMB. SERUM-BASED CALIB.
(FDA 510(k) Clearance)

K802741 · Union Carbide Corp. · Chemistry

Dec 1980

Decision

37d

Days

Class 2

Risk

K802741 is an FDA 510(k) clearance for the CENTRIFICHEM COMB. SERUM-BASED CALIB.. This device is classified as a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX).

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on December 10, 1980, 37 days after receiving the submission on November 3, 1980.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K802741 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 1980
Decision Date	December 10, 1980
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—