510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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JINClass I

Nitroprusside, Ketones (Urinary, Non-Quant.)

21 CFR 862.1435 / Clinical Chemistry
FDA source (opens on fda.gov)

JIN is the FDA product code for Nitroprusside, Ketones (Urinary, Non-Quant.), a class I device type, regulated under 21 CFR 862.1435. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 14 recalls.

Classification record

Product code
JIN
Device name
Nitroprusside, Ketones (Urinary, Non-Quant.)
Regulation
21 CFR 862.1435
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
24
Ingested recalls
14

Clearances, product code JIN

By decision year
24 clearances under product code JIN with a decision year between 1980 and 2020, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code JIN by decision year
YearClearances
19801
19833
19841
19851
19881
19903
19913
19962
20011
20041
20061
20171
20183
20202

Applicants with the most clearances

Product code JIN
Applicants holding the most 510(k) clearances under product code JIN
ApplicantClearances
Ihara Medics U.S., Inc.4
Abbott Medical2
I-SENS, Inc.2
Polymer Technology Intl.2
Acon Laboratories, Inc.1
Apex Biotechnology Corp.1
Gds Diagnostics1
Gds Technology, LLC1
Helena Laboratories, Corp.1
Kyoto Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 96 companies shown, in name order