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

IAF — Predicate Candidate Screening

33 FDA 510(k) clearances under this product code; the 50 most recent screened below.

22 daysmedian FDA review time

43 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days
K890673	WRIGHT-GLEMSA STAIN	Sigma Diagnostics, Inc.	1989-02-24	15
K890674	ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET	Sigma Diagnostics, Inc.	1989-02-24	15
K854236	HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS	Nms Pharmaceuticals, Inc.	1986-10-10	354
K860793	CAMCO STAIN PAK	Cambridge Chemical Products, Inc.	1986-03-18	14
K853241	HEMATOLOGY STAIN PACK	Fisher Scientific Co., LLC	1985-08-19	18
K852138	WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S	Canyon Diagnostics, Inc.	1985-06-13	28
K842744	WRIGHT STAIN	E K Ind., Inc.	1984-08-12	30
K842745	WRIGHT-GIEMSA QUICK STAIN	E K Ind., Inc.	1984-08-10	28
K833678	HEMATOLOGY WRIGHT'S STAIN PACK	J.S. Medical Assoc.	1983-11-25	38
K833260	STAIN PACK FOR AEROSPRAY SLIDE STAINER	Wescor, Inc.	1983-10-28	35
K831605	HEMATOLOGY PAK	Mercedes Scientific Co., Inc.	1983-06-30	43
K830542	HEMAQUIK II STAINING SOLUTION #55961	Accra Laboratories, Inc.	1983-03-17	23
K830127	QUIK-DIP BLOOD STAIN	Mercedes Scientific Co., Inc.	1983-02-15	34
K822981	MIDAS 1000 WRIGHT GIEMSA STAIN #66020	Emd Chemicals, Inc.	1982-10-27	19
K822980	MIDAS 1000 WRIGHT STAIN #66010	Emd Chemicals, Inc.	1982-10-27	19
K821457	HEMACOUNT WRIGHTS STAIN PACK II #55952	Accra Laboratories, Inc.	1982-06-01	15
K820437	AVES WRIGHT STAIN	Helena Laboratories	1982-03-26	37
K812848	ACCRA LAB HEMOTOLOGY	Accra Laboratories, Inc.	1981-10-23	14
K812504	ACCRA LAB WRIGHT STAIN	Accra Laboratories, Inc.	1981-09-23	22
K811400	HEMAQUIK	Accra Laboratories, Inc.	1981-06-18	31
K810495	STAT STAIN SET	Accra Laboratories, Inc.	1981-03-17	21
K801212	WRIGHTS RAPID STAIN	Mcb Manufacturing Chemists, Inc.	1980-05-30	10
K792497	VOLU-SOL STATIM STAIN	Volu Sol Medical Industries	1979-12-18	14
K792026	WRIGHTS RAPID STAIN	Mcb Manufacturing Chemists, Inc.	1979-11-13	35
K792017	VOLU-SOL STAT STAIN	Volu Sol Medical Industries	1979-10-30	21
K791929	WRIGHTS RAPID STAIN	Mcb Manufacturing Chemists, Inc.	1979-10-11	14
K790571	QUIK-STAIN	Dade, Baxter Travenol Diagnostics, Inc.	1979-04-23	31
K781587	HEMATOLOGY STAIN PACK	Bioscientific	1978-10-10	22
K781347	CAMCO QUIK STAIN II	Cambridge Chemical Products, Inc.	1978-08-21	14
K781384	WRIGHT RAPID STAIN	Mfg Chemists, Inc.	1978-08-21	10
K770074	BIO-DYES FORTIFIED HEMATOLOGY STAIN	Jack W. Kindberg	1977-03-22	68
K770075	BIO-DYES HEMATOLOGY PHOSPHATE	Jack W. Kindberg	1977-03-22	68
K760027	DSP - STAIN PACK	Harleco	1976-07-20	36

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