JIRClass I

Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

21 CFR 862.1645 / Clinical Chemistry

JIR is the FDA product code for Indicator Method, Protein Or Albumin (Urinary, Non-Quant.), a class I device type, regulated under 21 CFR 862.1645. As of 2026-09-10, FDA records hold 38 510(k) clearances under this code, the most recent dated 2023-09-08, and 7 recalls.

Classification record

Product code: JIR
Device name: Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Regulation: 21 CFR 862.1645
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: 38
Ingested recalls: 7

Clearances, product code JIR

By decision year

38 clearances under product code JIR with a decision year between 1981 and 2023, 1989 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code JIR by decision year
Year	Clearances
1981	1
1983	1
1986	1
1988	1
1989	6
1990	2
1991	3
1992	2
1994	1
1995	2
1996	4
1997	2
1998	2
1999	3
2000	2
2002	1
2007	1
2015	1
2022	1
2023	1

Applicants with the most clearances

Product code JIR

Applicants holding the most 510(k) clearances under product code JIR
Applicant	Clearances
Bayer Corp.	4
Boehringer Mannheim Corp.	3
Biotrol, USA, Inc.	2
Sekisui Diagnostics P.E.I. Inc.	2
Exocell, Inc.	2
Healthy.io Ltd.	2
Teco Diagnostics	2
Acon Laboratories, Inc.	1
Abbott Medical	1
American Diagnostic Corp.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order