# Helena Laboratories

- Location (FDA's records): Beaumont, TX
- FDA decisions: 282 (1978–2022): 282 510(k) clearances
- Names in FDA's records: Helena Laboratories (280); Helena Laboratories, Corp. (2)
- Product codes: LCP (19), GGP (17), JHO (15), CEF (15), KHE (12), JJY (11), CFE (11), JBD (11), JPA (8), JJN (8), GGN (7), CGS (7)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Array Medical, Inc.: 1 (https://510kreport.com/company/array-medical)
- Sebia: 1 (https://510kreport.com/company/sebia)

## Firms that cite its devices most
- Otsuka Pharmaceutical Co., Ltd.: 2 (https://510kreport.com/company/otsuka-pharmaceutical)
- Bio-Rad: 2 (https://510kreport.com/company/bio-rad)
- Universal Reagents, Inc.: 1 (https://510kreport.com/company/universal-reagents)
- Zaxis, Inc.: 1 (https://510kreport.com/company/zaxis)
- Cantebury Scientific, Ltd.: 1 (https://510kreport.com/company/cantebury-scientific)
- Tosoh Medics, Inc.: 1 (https://510kreport.com/company/tosoh-medics)

## Its most-cited devices
- K833611: Titan Gel Lipoprotein Electrophoresis (1984), cited by 2
- K792507: Helena Factor V Deficient Substrate (1979), cited by 1
- K933086: Afsc Hemo Control #5331, AA2 Hemo Control #5328 (1994), cited by 1
- K941872: Specialty Assayed Control-2 Cat. NO. 5302 (1994), cited by 1
- K823870: Beta Thalquik Column #5341 (1983), cited by 1
- K935162: Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit (1994), cited by 1

## Recent decisions
- K213396: SPIFE A1AT kit (Oct 13, 2022)
- K192931: V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (Apr 19, 2022)
- K131479: V8 SP Normal Control, Abnormal Control (Oct 7, 2013)
- K100103: Specialty Assayed Control-2 (Dec 15, 2010)
- K061991: Plateletworks Arachidonic Acid, Model PW-Aca (Feb 23, 2007)
- K061069: Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit, Model 3458 (Jul 6, 2006)
- K061014: Actalyke QC Kit, Models  Aqc-HP and Aqc-LP (May 10, 2006)
- K050053: Hemoram/Aggram Analyzer (Jul 11, 2005)

Source page: https://510kreport.com/company/helena-laboratories