# Orion Diagnostica, Inc.

- Location (FDA's records): Mchenry, IL
- FDA decisions: 32 (1980–2016): 32 510(k) clearances
- Names in FDA's records: Orion Diagnostica, Inc. (28); Orion Diagnostica, OY (4)
- Product codes: LIQ (3), GON (2), DCK (2), GOD (2), GTY (1), GRJ (1), LYR (1), CZP (1), JJY (1), DFT (1), JSI (1), GQS (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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
- Horiba Abx: 1 (https://510kreport.com/company/horiba-abx)
- Procise Diagnostics: 1 (https://510kreport.com/company/procise-diagnostics)

## Its most-cited devices
- K142993: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (2016), cited by 2

## Recent decisions
- K142993: QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument (Mar 10, 2016)
- K043125: Orion Diagnostica Uniq Pinp Ria (May 4, 2005)
- K042625: Quikread CRP Calibrator Set (Nov 18, 2004)
- K042442: Quickread System: Quickread CRP Kit, Model 06085; Quickread 101 Instrument, Model 06088; Quickread CRP Control Set, Mode (Sep 24, 2004)
- K942286: Diarlex Rota-Adeno (Dec 14, 1994)
- K914892: Saliva-Stim (Sep 2, 1992)
- K904655: Pyloriset (Oct 21, 1991)
- K884147: Immunochemical Determination of Immunoglobulin M (Oct 27, 1988)

Source page: https://510kreport.com/company/orion-diagnostica