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

Incstar Corp. — Predicate Candidate Screening

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

94 daysmedian FDA review time

245 days90th percentile

58clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K963289	INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY	Incstar Corp.	1997-05-01	253	0
K963296	INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565)	Incstar Corp.	1996-12-16	117	0
K963297	INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)	Incstar Corp.	1996-12-16	117	0
K960367	INCSTAR RUBELLA IGG ELISA ASSAY	Incstar Corp.	1996-10-24	273	1
K960358	INCSTAR RUBELLA IGG FAST ELISA ASSAY	Incstar Corp.	1996-10-24	273	0
K960434	INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530	Incstar Corp.	1996-10-17	260	0
K953567	INCSTAR 25-HYDROXYVITMIN D 1251 RIA	Incstar Corp.	1996-09-25	422	1
K955363	INCSTAR HSZ I/II IGG ELISA ASSAY	Incstar Corp.	1996-07-24	245	0
K955362	INCSTAR HSV I/II IGG FAST ELISA ASSAY	Incstar Corp.	1996-07-24	245	0
K955361	INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY	Incstar Corp.	1996-07-22	243	0
K955360	INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY	Incstar Corp.	1996-07-22	243	0
K951639	COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)	Incstar Corp.	1995-10-13	186	0
K946158	INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT	Incstar Corp.	1995-06-09	183	1
K946159	INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KI	Incstar Corp.	1995-06-07	181	0
K946157	INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) LGM ELISA KI	Incstar Corp.	1995-06-07	181	0
K941168	CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY K	Incstar Corp.	1994-09-07	177	0
K940271	INCSTAR ACTH IRMA	Incstar Corp.	1994-08-02	193	0
K934966	SPQ PAL CONTROL LEVEL II	Incstar Corp.	1994-01-11	88	0
K935075	SPQ CRP CONTROL LEVEL II	Incstar Corp.	1994-01-11	78	0
K934521	SPQ MALB CONTROL LEVEL II	Incstar Corp.	1993-11-26	70	0
K921628	EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA	Incstar Corp.	1992-09-14	161	0
K921616	CMV-VUE(TM) CMV ANTIGEN DETECTION KIT	Incstar Corp.	1992-08-11	127	0
K921629	N-TACT(R) PTH SP KIT	Incstar Corp.	1992-05-14	38	0
K915235	CLINICAL ASSAYS GAMMA COAT FREE T4 RADIOIMM. KIT	Incstar Corp.	1992-01-28	67	0
K915570	GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT	Incstar Corp.	1992-01-27	46	0
K902639	EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)	Incstar Corp.	1990-08-22	69	0
K901711	PTH-MM II 125I RADIOIMMUNOASSAY (RIA)	Incstar Corp.	1990-07-16	94	0
K900939	SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)	Incstar Corp.	1990-05-16	77	0
K893393	EPO-TRAC BY RADIOIMMUNOASSAY (RIA)	Incstar Corp.	1989-11-21	204	0
K895496	BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA	Incstar Corp.	1989-10-17	69	0
K875110	HOUSE DUST; HOLLISTER-STIER (H/S) ALLERGEN DISC	Incstar Corp.	1988-06-14	183	0
K880168	INCSTAR'S BIRCH ALLERGEN DISC	Incstar Corp.	1988-05-11	117	0
K880221	INCSTAR'S PIGWEED ALLERGEN DISC	Incstar Corp.	1988-05-11	112	0
K874540	MARSH ELDER ALLERGEN DISC	Incstar Corp.	1988-05-11	190	0
K874883	WALNUT ALLERGEN DISC	Incstar Corp.	1988-05-11	162	0
K880187	INCSTAR'S DANDELION ALLERGEN DISC	Incstar Corp.	1988-04-21	97	0
K880567	WHITE ASH ALLERGEN DISC	Incstar Corp.	1988-04-21	71	0
K875163	GOLDENROD ALLERGEN DISC	Incstar Corp.	1988-04-21	127	0
K880415	MESQUITE ALLERGEN DISC	Incstar Corp.	1988-04-21	80	0
K874541	RRT TOTAL IGE TEST KIT	Incstar Corp.	1988-02-17	106	0
K875274	TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))	Incstar Corp.	1988-02-17	55	0
K874440	LIVE OAK ALLERGEN DISC	Incstar Corp.	1987-11-25	28	0
K874299	N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)	Incstar Corp.	1987-11-23	34	0
K874149	FALSE RAGWEED ALLERGEN DISC	Incstar Corp.	1987-11-04	22	0
K874150	JOHNSON GRASS ALLERGEN DISC	Incstar Corp.	1987-11-04	22	0
K873969	GIANT RAGWEED ALLERGEN DISC	Incstar Corp.	1987-11-04	36	0
K873814	IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST	Incstar Corp.	1987-10-20	29	0
K873770	BERMUDA GRASS ALLERGEN DISC	Incstar Corp.	1987-10-20	34	0
K873648	BAHIA ALLERGEN DISC	Incstar Corp.	1987-10-08	29	0
K873486	RED TOP ALLERGEN DISC	Incstar Corp.	1987-10-07	37	0

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