Cleared Traditional

K875029 - ABBOTT BREATH ACETONE ANALYZER (FDA 510(k) Clearance)

K875029 · Abbott Laboratories · Chemistry device

May 1988

Decision

172d

Days

Class 1

Risk

K875029 is an FDA 510(k) clearance for the ABBOTT BREATH ACETONE ANALYZER. This device is classified as a Nitroprusside, Ketones (urinary, Non-quant.) (Class I - General Controls, product code JIN).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 27, 1988, 172 days after receiving the submission on December 7, 1987.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1435.

Submission Details

510(k) Number	K875029 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 07, 1987
Decision Date	May 27, 1988
Days to Decision	172 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JIN — Nitroprusside, Ketones (urinary, Non-quant.)
Device Class	Class I - General Controls
CFR Regulation	21 CFR 862.1435