Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Kent Laboratories, Inc. — Predicate Candidate Screening

40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

55 daysmedian FDA review time

253 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days
K951966	HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT	Kent Laboratories, Inc.	1995-06-01	35
K951967	HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNO	Kent Laboratories, Inc.	1995-05-30	33
K951968	HUMAN C1Q RADIAL IMMUNODIFFUSION KIT	Kent Laboratories, Inc.	1995-05-30	33
K950102	HUMAN C-5 RADIAL IMMUNODIFFUSION KIT	Kent Laboratories, Inc.	1995-04-10	89
K850683	72 DETERM. SIZE RADIAL IMMUNODIFFUSION TEST ALPHA2	Kent Laboratories, Inc.	1985-11-27	279
K850682	72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL	Kent Laboratories, Inc.	1985-11-25	277
K850690	ANTISERUM TO HUMAN APOLIPOPROTEIN B	Kent Laboratories, Inc.	1985-11-01	253
K850691	ANTISERUM TO HUMAN APOLIPOPROTEIN A-I	Kent Laboratories, Inc.	1985-11-01	253
K850686	ANTISERUM TO HUMAN PREALBUMIN	Kent Laboratories, Inc.	1985-11-01	253
K831961	IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN	Kent Laboratories, Inc.	1983-08-11	55
K831959	RADIAL IMMUNO-TEST FOR HUMAN FACTOR B	Kent Laboratories, Inc.	1983-07-19	32
K831958	RADIAL IMMUNO-TEST FOR HUMAN C-REACTI	Kent Laboratories, Inc.	1983-07-19	32
K831960	TEST FOR HUMAN ALPHA ONE ACID GLYCO-	Kent Laboratories, Inc.	1983-07-19	32
K831956	DETERM. SIZE 72 RADIAL-HUMAN IGD	Kent Laboratories, Inc.	1983-07-18	31
K831957	DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB	Kent Laboratories, Inc.	1983-07-18	31
K823765	ANTI SERA TO HUMAN OROSCOMUCOID	Kent Laboratories, Inc.	1982-12-30	16
K822472	ANTISERA TO HUMAN FERRITIN	Kent Laboratories, Inc.	1982-09-30	44
K811613	72 DETERMIN. SIZE RADIAL IMMUNOD. TEST	Kent Laboratories, Inc.	1981-08-12	65
K790706	ANTISERUM TO RABBIT IGG H & L CHAIN	Kent Laboratories, Inc.	1979-09-12	153
K790702	ANTISERUM, HUMAN, IGG H & L CHAIN	Kent Laboratories, Inc.	1979-09-04	145
K790713	ANTISERUM TO HUMAN HEMOPEXIN	Kent Laboratories, Inc.	1979-09-04	145
K790711	ANTISERA TO HUMAN FRAGMENT	Kent Laboratories, Inc.	1979-09-04	145
K790708	ANTISERUM TO HUMAN IG G FC FRAGMENTS	Kent Laboratories, Inc.	1979-08-22	132
K790712	ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI	Kent Laboratories, Inc.	1979-08-16	126
K790714	ANTISERUM TO HUMAN CERULOPLASMIN	Kent Laboratories, Inc.	1979-08-16	126
K790720	ANTISERA TO RABBIT IMMUNOGLOBULIN	Kent Laboratories, Inc.	1979-08-16	126
K790715	ANTISERUM TO HUMAN FC	Kent Laboratories, Inc.	1979-08-16	126
K790709	ANTISERUM TO RABBIT IMMUNOGLOBULIN	Kent Laboratories, Inc.	1979-08-16	126
K790716	ANTISERUM TO HUMAN C-REACTIVE PROTEINS	Kent Laboratories, Inc.	1979-08-03	113
K790710	ANTISERUM TO HUMAN ALPHA-2-MACROBLOBULIN	Kent Laboratories, Inc.	1979-08-03	113
K790704	ANTISERUM TO HUMAN IGG	Kent Laboratories, Inc.	1979-04-12	0
K790703	ANTISERUM, HUMAN, IGA	Kent Laboratories, Inc.	1979-04-12	0
K790705	ANTISERUM TO HUMAN IGM	Kent Laboratories, Inc.	1979-04-12	0
K771242	ANTISERA TO HUMAN FAB FRAGMENT	Kent Laboratories, Inc.	1977-08-03	23
K771243	ANTISERA TO HUMAN FAB FRAGMENT	Kent Laboratories, Inc.	1977-08-03	23
K771144	RHODAMINE-CONJUGATED ANTISERUM	Kent Laboratories, Inc.	1977-07-14	17
K770669	RHODAMINE-CONJUGATED ANTISERUM	Kent Laboratories, Inc.	1977-04-28	20
K770670	FLOR. CONJUG. HUMAN FAB FRAGMENT	Kent Laboratories, Inc.	1977-04-28	20
K770668	FLUORESCEIN CONJUGATED ANTISERUM	Kent Laboratories, Inc.	1977-04-28	20
K770484	FLUOR. CONJUGATED ANTISERUM	Kent Laboratories, Inc.	1977-03-21	7

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda