JIN · Class I · 21 CFR 862.1435

FDA Product Code JIN: Nitroprusside, Ketones (urinary, Non-quant.)

Leading manufacturers include I-Sens, Inc., ACON Laboratories, Inc. and Taidoc Technology Corporation.

24
Total
24
Cleared
135d
Avg days
1980
Since

FDA 510(k) Cleared Nitroprusside, Ketones (urinary, Non-quant.) Devices (Product Code JIN)

24 devices
1–24 of 24
Cleared Sep 09, 2020
KetoSens BT Blood B-Ketone Monitoring System
K201551
I-Sens, Inc.
Chemistry · 92d
Cleared Jun 05, 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 228d
Cleared Dec 18, 2018
KET-1 Blood Ketone Monitoring System
K182593
Apex BioTechnology Corp.
Chemistry · 89d
Cleared May 04, 2018
TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System
K173345
Taidoc Technology Corporation
Chemistry · 192d
Cleared Apr 13, 2018
KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
K170463
I-Sens, Inc.
Chemistry · 422d
Cleared Jul 06, 2017
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
K170587
ACON Laboratories, Inc.
Chemistry · 128d
Cleared May 27, 1988
ABBOTT BREATH ACETONE ANALYZER
K875029
Abbott Laboratories
Chemistry · 172d
Cleared Aug 30, 1985
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K850368
Sigma Chemical Co.
Chemistry · 211d
Cleared May 04, 1983
HELENA BIOSTRIP K
K830976
Helena Laboratories
Chemistry · 36d

About Product Code JIN - Regulatory Context