# Bayer Healthcare, LLC

- Location (FDA's records): Tarrytown, NY
- FDA decisions: 58 (1980–2018): 55 510(k) clearances and 3 original PMA approvals
- Names in FDA's records: Bayer Healthcare, LLC (48); Bayer Healthcare (10)
- Product codes: NBW (13), JIX (6), NBC (5), LFR (4), JJY (3), MMI (2), NUH (2), GKZ (2), LOL (1), JFM (1), LCP (1), KLT (1)
- Predicates its devices cite: 56 (21 its own); citations of its devices by later devices: 66 (21 its own)
- Recalls linked to its devices: 60 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bayer Corp.: 11 (https://510kreport.com/company/bayer)
- Bayer Diagnostics Corp.: 4 (https://510kreport.com/company/bayer-diagnostics)
- Ciba Corning Diagnostics Corp.: 3 (https://510kreport.com/company/ciba-corning-diagnostics)
- Heraeus Kulzer, Inc.: 2 (https://510kreport.com/company/heraeus-kulzer)
- Lifescan, Inc.: 2 (https://510kreport.com/company/lifescan)
- Hollywog, LLC: 1 (https://510kreport.com/company/hollywog)
- Abbott Diagnostics: 1 (https://510kreport.com/company/abbott-diagnostics)
- Technicon Instruments Corp.: 1 (https://510kreport.com/company/technicon-instruments)

## Firms that cite its devices most
- Siemens Healthcare Diagnostics, Inc.: 11 (https://510kreport.com/company/siemens-healthcare-diagnostics)
- ACON Laboratories, Inc.: 3 (https://510kreport.com/company/acon-laboratories)
- Ascensia Diabetes Care U.S., Inc.: 3 (https://510kreport.com/company/ascensia-diabetes-care-us)
- Ascensia Diabetes Care: 2 (https://510kreport.com/company/ascensia-diabetes-care)
- Beckman Coulter, Inc.: 2 (https://510kreport.com/company/beckman-coulter)
- Bayer Diagnostics Corp.: 2 (https://510kreport.com/company/bayer-diagnostics)
- Bionostics, Inc.: 2 (https://510kreport.com/company/bionostics)
- Fujirebio Diagnostics,Inc.: 1 (https://510kreport.com/company/fujirebio-diagnostics)

## Its most-cited devices
- K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 (2006), cited by 7
- K041133: Modification to Bayer Advia Centaur Automated Chemiluminescence Analyzer (2004), cited by 5
- K031947: Bayer Clinitek Status Analyzer (2003), cited by 4
- K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec (2009), cited by 3
- K091820: Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System (2009), cited by 3
- K031038: Advia Centaur B-Type Natriuretic Peptide (BNP) Assay (2003), cited by 3

## Recent decisions
- K171802: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (Mar 7, 2018)
- K152852: ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (Dec 22, 2015)
- K150942: Contour Next USB Blood Glucose Monitoring System (Nov 25, 2015)
- K151742: Contour Next Control Solution (Sep 23, 2015)
- K130265: Contour Next EZ Blood Glucose Meter (Jun 23, 2014)
- K122370: Contour Next Link Wireless Blood Glucose Monitor (Sep 26, 2013)
- K121190: Contour Next Blood Glucose Meter (Jul 26, 2012)
- K121087: Contour Next Usb Blood Glucose Monitoring System (Jun 28, 2012)

Source page: https://510kreport.com/company/bayer-healthcare