# Remel Co.

- Location (FDA's records): Lenexa, KS
- FDA decisions: 164 (1979–2017): 164 510(k) clearances
- Names in FDA's records: Remel Co. (137); Remel, Inc. (17); Remel, L.P. (10)
- Product codes: JTO (49), JTN (17), JTS (12), JSJ (11), JSI (9), JSM (6), JSO (6), LIO (5), JSF (4), JSN (2), MJD (2), LLH (2)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 25 (1 its own)
- Recalls linked to its devices: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Genzyme Diagnostics: 3 (https://510kreport.com/company/genzyme-diagnostics)
- Techlab, Inc.: 2 (https://510kreport.com/company/techlab)
- Hardy Diagnostics: 1 (https://510kreport.com/company/hardy-diagnostics)
- Meridian Diagnostics, Inc.: 1 (https://510kreport.com/company/meridian-diagnostics)

## Firms that cite its devices most
- Techlab, Inc.: 4 (https://510kreport.com/company/techlab)
- Binax, Inc.: 2 (https://510kreport.com/company/binax)
- Hardy Diagnostics: 2 (https://510kreport.com/company/hardy-diagnostics)
- Trinity Biotech, Plc: 2 (https://510kreport.com/company/trinity-biotech)
- bioMerieux, Inc.: 2 (https://510kreport.com/company/biomerieux)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Meridian Bioscience, Inc.: 1 (https://510kreport.com/company/meridian-bioscience)

## Its most-cited devices
- K972359: Remel Bile Esculin Azide Agar W/6 MCG/ML Vancomycin (1997), cited by 6
- K031565: Xpect Influenza a/B (2003), cited by 4
- K041951: Xpect Clostridium Difficile Toxin a/B (2004), cited by 3
- K850291: Mueller Hinton Agar W/4% Nacl W/Antibiotics (1985), cited by 3
- K031942: Xpect Giardia Lateral Flow Assay, Model 2450020 (2003), cited by 2
- K871447: Todd Hewitt W/Cna (Lim Broth) (1987), cited by 2

## Recent decisions
- K162620: Remel Spectra ESBL (May 1, 2017)
- K131804: Remel Xpect Flu a&B (Jul 12, 2013)
- K092407: Remel Spectra Mrsa (Oct 8, 2010)
- K072827: Rpmi 1640 Agar W/Mops and 2% Glucose (Nov 26, 2007)
- K041951: Xpect Clostridium Difficile Toxin a/B (Nov 15, 2004)
- K033479: Prospect Clostridium Difficile Toxin a/B Microplate Assay (Feb 26, 2004)
- K031942: Xpect Giardia Lateral Flow Assay, Model 2450020 (Nov 18, 2003)
- K031965: Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 (Nov 14, 2003)

Source page: https://510kreport.com/company/remel