Cleared Traditional

CENTRIFICHEM FILTER CALIBRATION SET

K800304 · Union Carbide Corp. · Chemistry
Mar 1980
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K800304 is an FDA 510(k) clearance for the CENTRIFICHEM FILTER CALIBRATION SET, a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980, 29 days after receiving the submission on February 12, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K800304 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1980
Decision Date March 12, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIW — Calibrator, Surrogate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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