JIYClass I

Photometric Method, Iron (Non-Heme)

21 CFR 862.1410 / Clinical Chemistry

JIY is the FDA product code for Photometric Method, Iron (Non-Heme), a class I device type, regulated under 21 CFR 862.1410. As of 2026-09-10, FDA records hold 67 510(k) clearances under this code, the most recent dated 2006-08-07, and 19 recalls.

Classification record

Product code: JIY
Device name: Photometric Method, Iron (Non-Heme)
Regulation: 21 CFR 862.1410
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: 67
Ingested recalls: 19

Clearances, product code JIY

By decision year

67 clearances under product code JIY with a decision year between 1977 and 2006, 1988 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code JIY by decision year
Year	Clearances
1977	1
1978	1
1979	1
1980	1
1981	2
1982	1
1983	2
1984	3
1985	3
1986	5
1987	6
1988	7
1989	7
1990	4
1991	2
1992	2
1993	2
1994	3
1995	2
1996	1
1997	3
1998	1
2001	1
2002	1
2003	1
2004	1
2005	1
2006	2

Applicants with the most clearances

Product code JIY

Applicants holding the most 510(k) clearances under product code JIY
Applicant	Clearances
Em Diagnostic Systems, Inc.	7
Data Medical Associates, Inc.	5
American Dade	2
American Monitor Corp.	2
Catachem, Inc.	2
Clinical Data, Inc.	2
Siemens Healthcare Diagnostics Inc.	2
Sekisui Diagnostics P.E.I. Inc.	2
Eastman Kodak Company	2
Olympus Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order