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

Kallestad Laboratories, Inc. · Predicate Candidate Screening

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

28 daysmedian FDA review time

82 days90th percentile

92clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K863681	PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM	Kallestad Laboratories, Inc.	1986-12-03	75	0
K862917	PATHFINDER ROTAVIRUS CHEMILUMINESCENT	Kallestad Laboratories, Inc.	1986-10-22	82	0
K863682	PATHFINDER(TM) SPECIMEN COLLECTION KIT	Kallestad Laboratories, Inc.	1986-10-10	21	0
K862743	PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS	Kallestad Laboratories, Inc.	1986-09-29	70	0
K862313	KALLESTAD SM/RNP TEST REAGENT	Kallestad Laboratories, Inc.	1986-08-06	49	0
K862710	KALLESTAD SSA/SSB ENA TEST REAGENTS	Kallestad Laboratories, Inc.	1986-07-29	13	0
K855014	QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A	Kallestad Laboratories, Inc.	1986-03-14	88	0
K855010	QUANTIMETRIC PLUS IGM REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-28	74	0
K855007	QUANTIMETRIC PLUS LAMBDA REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-26	72	0
K855012	QUANTIMETRIC PLUS C4 REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-26	72	0
K855008	QUANTIMETRIC PLUS KAPPA REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-26	72	0
K855009	QUANTIMETRIC PLUS IGA REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-26	72	0
K855011	QUANTIMETRIC PLUS C3 REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-26	72	0
K855013	QUANTIMETRIC PLUS SUPPORT PACK	Kallestad Laboratories, Inc.	1986-02-26	72	0
K854483	KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT	Kallestad Laboratories, Inc.	1985-12-11	34	0
K853554	PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUS	Kallestad Laboratories, Inc.	1985-11-26	92	0
K852999	QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT	Kallestad Laboratories, Inc.	1985-10-21	98	0
K852794	ALLERCOAT ALLERGEN DISCS	Kallestad Laboratories, Inc.	1985-09-19	80	0
K852125	PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP	Kallestad Laboratories, Inc.	1985-07-30	76	0
K852268	QUANTICLONE IGE RADIOIMMUNASSAY	Kallestad Laboratories, Inc.	1985-07-10	43	0
K841864	QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT	Kallestad Laboratories, Inc.	1984-07-11	68	0
K842125	ALLERCOAT ALLERGEN DISCS	Kallestad Laboratories, Inc.	1984-06-07	9	0
K840360	ALLERCOAT MULTISCREEN DISCS	Kallestad Laboratories, Inc.	1984-03-09	43	0
K831326	ALLERCOAT ALLERGEN DISCS	Kallestad Laboratories, Inc.	1983-06-02	38	0
K823403	ALLERCOAT POSITIVE CONTROL SERUM	Kallestad Laboratories, Inc.	1982-12-15	30	0
K823470	ALLERCOAT ALLERGEN DISCS	Kallestad Laboratories, Inc.	1982-12-15	23	0
K823107	QUANTIMETRIC 2 CERULOPLASMIN ASSAY	Kallestad Laboratories, Inc.	1982-11-16	26	0
K822613	RAST ALLERCOAT ALLERGEN DISCS	Kallestad Laboratories, Inc.	1982-10-22	53	0
K822206	TOTAL IGE DISCS	Kallestad Laboratories, Inc.	1982-08-16	21	0
K822133	IGE/THE OPHYLLINE CONTROL SERUM I,II,III	Kallestad Laboratories, Inc.	1982-08-03	14	0
K821984	QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.	Kallestad Laboratories, Inc.	1982-07-22	16	0
K821862	QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.	Kallestad Laboratories, Inc.	1982-07-06	12	0
K812416	MARK 500 SYSTEM	Kallestad Laboratories, Inc.	1982-04-08	227	0
K820029	KALLESTAD RAST REAGENTS	Kallestad Laboratories, Inc.	1982-04-06	91	0
K813592	QUANTAFLUOR FLUORESCENT TEST REAGENTS	Kallestad Laboratories, Inc.	1982-01-18	21	2
K813242	QUANTIMETRIC 2 TEST KIT	Kallestad Laboratories, Inc.	1981-12-02	15	0
K812411	IMMUNO-CELL IMMUNO-SEP KIT	Kallestad Laboratories, Inc.	1981-11-10	81	0
K812611	QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO	Kallestad Laboratories, Inc.	1981-10-02	17	0
K812414	KALLESTAD 125I ANTISERUM TO HUMAN IGE	Kallestad Laboratories, Inc.	1981-09-14	24	0
K812415	KALLESTAD ANTISERA TO TOBRAMYCIN	Kallestad Laboratories, Inc.	1981-09-09	9	0
K812327	KAPPA & LAMBDA BENCE JONES CONTROLS	Kallestad Laboratories, Inc.	1981-09-01	14	0
K812050	KALLESTAD ANTISERA TO GENTAMICIN	Kallestad Laboratories, Inc.	1981-08-03	13	0
K811740	KALLESTAD'S ENDOPLATE FACTOR B TEST	Kallestad Laboratories, Inc.	1981-07-16	27	0
K811776	KALLESTAD QUANTICOAT 125 DIGOXIN	Kallestad Laboratories, Inc.	1981-07-10	17	0
K811775	KALLESTAD ANTISERA TO PHENYTOIN	Kallestad Laboratories, Inc.	1981-07-10	17	0
K811617	QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.	Kallestad Laboratories, Inc.	1981-06-25	17	0
K811545	KALLESTAD QUANTITOPE LOW LEVEL IGE REAG	Kallestad Laboratories, Inc.	1981-06-24	23	0
K811445	KALLESTAD R QUANTIPLATE ALT. PATHWAY T.	Kallestad Laboratories, Inc.	1981-06-24	33	0
K811367	KALLESTAD ANTISERA TO PHENOBARBITAL	Kallestad Laboratories, Inc.	1981-05-29	15	0
K810863	KALLESTAD HEP-2 CELL LINE SUBSTRATE	Kallestad Laboratories, Inc.	1981-04-14	14	1

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