# Tianjin New Bay Bioresearch Co., Ltd.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 11 (2005–2013): 11 510(k) clearances
- Product codes: DJG (5), DKZ (3), NBW (1), KHE (1), LCX (1)
- Predicates its devices cite: 12 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Branan Medical Corp.: 2 (https://510kreport.com/company/branan-medical)
- Microgenics Corp.: 2 (https://510kreport.com/company/microgenics)
- Alfa Scientific Designs, Inc.: 1 (https://510kreport.com/company/alfa-scientific-designs)
- Lifescan, Inc.: 1 (https://510kreport.com/company/lifescan)
- Guangzhou Wondfo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Armkel, LLC: 1 (https://510kreport.com/company/armkel)
- Ucp Biosciences, Inc.: 1 (https://510kreport.com/company/ucp-biosciences)

## Firms that cite its devices most
- Alfa Scientific Designs, Inc.: 1 (https://510kreport.com/company/alfa-scientific-designs)

## Its most-cited devices
- K052882: Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device (2006), cited by 2
- K042988: Rapid One Step Buprenorphine Test Card (2005), cited by 1
- K042990: For Sure One Step Buprenorphine Test Strip (2005), cited by 1

## Recent decisions
- K130275: Quikscreen Multi (Mdma and Opi) Otc Drug Cup Test (Sep 26, 2013)
- K122064: Forsure One Step Buprenorphine Cup Test Device (May 7, 2013)
- K112449: Quikresponse One Step Midstream Early Pregrancy Test (Sep 24, 2012)
- K071489: Homecheck Multiple Drug Cup Test (Mar 28, 2008)
- K073431: Forsure Ifob Duel Sample Fecal Occult Blood Test Device (for Professional and Home Use); (for Professional); (for Home T (Jan 14, 2008)
- K061617: Forsure One Step Dip & Read (X) Drug Screen Test (Nov 22, 2006)
- K052520: Rapid Forsure One Step Multiple Drug (UP to 6) Screen Test Device for Amphetamine, Methamphetamine, Benzoylecgonine, THC (Apr 24, 2006)
- K052882: Forsure Rapid One Step Multiple (X) Abuse Drug Screen Test Cup Device (Feb 15, 2006)

Source page: https://510kreport.com/company/tianjin-new-bay-bioresearch