# Orgentec

- Location (FDA's records): Windham, NH
- FDA decisions: 10 (1995–1996): 10 510(k) clearances
- Product codes: LJM (4), LLL (2), LKP (1), LRM (1), JIR (1), LKO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Inova Diagnostics, Inc.: 1 (https://510kreport.com/company/inova-diagnostics)

## Its most-cited devices
- K954830: Orgentec Anti-SM (Smith) Pin Immuno Assay (1996), cited by 1

## Recent decisions
- K954830: Orgentec Anti-SM (Smith) Pin Immuno Assay (May 8, 1996)
- K954831: Orgentec Anti-RNP/SM Pin Immuno Assay (May 8, 1996)
- K954832: Orgentec Anti-SS-B (LA) Pin Immuno Assay (Apr 18, 1996)
- K954814: Orgentec Anti-SCL 70 Pin Immuno Assay (Apr 18, 1996)
- K954815: Orgentec Anti-SS-a (RO) Pin Immuno Assay (Apr 18, 1996)
- K954829: Orgentec Anti-JO-1 Pin Immuno Assay (Apr 18, 1996)
- K960274: Orgentec Micro-Albumin Pin Eia Assay (Mar 29, 1996)
- K955134: Orgentec Enascreen Elisa Assay (Mar 20, 1996)

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