Cleared Traditional

ABSORBANCE (ABS) TEST PAK

K854784 · Diagnostic Systems · Chemistry
Dec 1985
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K854784 is an FDA 510(k) clearance for the ABSORBANCE (ABS) TEST PAK, a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on December 19, 1985, 20 days after receiving the submission on November 29, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K854784 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1985
Decision Date December 19, 1985
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIT — Calibrator, Secondary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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