# Branan Medical Corp.

- Location (FDA's records): Irvine, CA
- FDA decisions: 24 (2000–2013): 24 510(k) clearances
- Names in FDA's records: Branan Medical Corp. (13); Branan Medical Corporation (11)
- Product codes: DIO (5), DJG (3), DKZ (3), LDJ (3), DJC (2), MLK (1), DJR (1), LCM (1), DOE (1), JXM (1), DIS (1), JXN (1)
- Predicates its devices cite: 7 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 15 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- OraSure Technologies, Inc.: 5 (https://510kreport.com/company/orasure-technologies)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)
- Amedica Biotech, Inc.: 1 (https://510kreport.com/company/amedica-biotech)

## Firms that cite its devices most
- Tianjin New Bay Bioresearch Co., Ltd.: 2 (https://510kreport.com/company/tianjin-new-bay-bioresearch)
- Premier Biotech, Inc.: 1 (https://510kreport.com/company/premier-biotech)
- Biochemical Diagnostics, Inc.: 1 (https://510kreport.com/company/biochemical-diagnostics)
- ACON Laboratories, Inc.: 1 (https://510kreport.com/company/acon-laboratories)

## Its most-cited devices
- K004034: Monitect Multiple Drug Screen Tests, Model BC12,BC14,TC10,PC11, and PC12 (2001), cited by 2
- K103227: Oratect Oral Fluid Drug Screen Devices (2012), cited by 2
- K002337: Branan Medical Corporation Monitect Barbiturates Drug Screen Test (2000), cited by 1

## Recent decisions
- K122633: Toxcup Drug Screen Cup (Feb 7, 2013)
- K122752: Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug Screen Dipcard (Jan 30, 2013)
- K103227: Oratect Oral Fluid Drug Screen Devices (Apr 11, 2012)
- K082508: Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard (Nov 21, 2008)
- K040203: Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen Dipstick Test, Model MF22 (Mar 25, 2004)
- K032057: Toxcup Drug Screen Cup Amp/Coc/Met/Opi/PCP/THC (Aug 21, 2003)
- K030113: Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen Dipstick Test, Model MD23 (Jul 2, 2003)
- K023489: Quicktox Multiple Drug Dipcard (Dec 16, 2002)

Source page: https://510kreport.com/company/branan-medical