Orion Diagnostica, Inc.
Espoo, FI
Orion Diagnostica, Inc. appears in FDA device records in Espoo, FI. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 32
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 32 510(k) clearances for Orion Diagnostica, Inc. between 1980 and 2016. The busiest year on record is 1980, with 11. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 11 |
| 1981 | 2 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 2 |
| 1988 | 4 |
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 2004 | 2 |
| 2005 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument | DCK | Substantially Equivalent | |
| K043125 | ORION DIAGNOSTICA UNIQ PINP RIA | CIN | Substantially Equivalent | |
| K042625 | QUIKREAD CRP CALIBRATOR SET | JJY | Substantially Equivalent | |
| K042442 | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE | DCK | Substantially Equivalent | |
| K942286 | DIARLEX ROTA-ADENO | LIQ | Substantially Equivalent | |
| K914892 | SALIVA-STIM | EGD | Substantially Equivalent | |
| K904655 | PYLORISET | LYR | Substantially Equivalent | |
| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | DFT | Substantially Equivalent | |
| K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G | DAH | Substantially Equivalent | |
| K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN | DDG | Substantially Equivalent | |
| K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A | CZP | Substantially Equivalent | |
| K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST | GOD | Substantially Equivalent | |
| K871196 | RHEUMA-CHECK ENZYME IMMUNOASSAY TEST | DHR | Substantially Equivalent | |
| K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST | GTY | Substantially Equivalent | |
| K854129 | ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS | LIQ | Substantially Equivalent | |
| K844399 | RESPIRALEX LATEX AGGLUTINATION TEST | GTZ | Substantially Equivalent | |
| K841319 | ROTALEX LATEX AGGLUTINATION TEST | LIQ | Substantially Equivalent | |
| K831124 | BIOCULT - GC CULTURE-PADDLES | JTY | Substantially Equivalent | |
| K821659 | RESPIRACULT-STREP DEEP BED CULTURE PAD | JSH | Substantially Equivalent | |
| K802931 | INFLUENZA A & B S-ANTIGEN & CONTROLS | GNX | Substantially Equivalent | |
| K802930 | CYTOMEGALO VIRUS & CONTROLS | GQH | Substantially Equivalent | |
| K802939 | HERPES SIMPLEX TYPE I | GON | Substantially Equivalent | |
| K802938 | VARICELLA-ZOSTER ANTIGENS & CONTROLS | GQW | Substantially Equivalent | |
| K802937 | RUBELLA VIRUS ANTIGENS & CONTROLS | GON | Substantially Equivalent | |
| K802936 | RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & | GQG | Substantially Equivalent | |
| K802935 | PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR | GQS | Substantially Equivalent | |
| K802934 | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL | GSB | Substantially Equivalent | |
| K802933 | MUMPS S & V ANTIGENS & CONTROLS | GRC | Substantially Equivalent | |
| K802932 | MEASLES VIRUS & CONTROLS | GRJ | Substantially Equivalent | |
| K802929 | ADENO VIRUS & CONTROLS | GOD | Substantially Equivalent | |
| K802947 | ORICULT DTM | JSI | Substantially Equivalent | |
| K802946 | MYCOLOGY CULTURE SYSTEM | JSJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GQHAntigen, Cf (Including Cf Control), Cytomegalovirus
- GRCAntigen, Cf (Including Cf Control), Mumps Virus
- GONAntigen, Cf (Including Cf Control), Rubella
- GQGAntigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
- GRJAntigen, Cf, (Including Cf Control), Rubeola
- GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster
- GTYAntigens, All Groups, Streptococcus Spp.
- GODAntigens, Cf (Including Cf Control), Adenovirus 1-33
- GNXAntigens, Cf (Including Cf Control), Influenza Virus A, B, C
- GQSAntigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
- GSBAntigens, Cf, All, Mycoplasma Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JTYCulture Media, For Isolation Of Pathogenic Neisseria
- JSHCulture Media, Non-Selective And Differential
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- LIQEnzyme Linked Immunoabsorbent Assay, Rotavirus
- DAHGamma Globulin, Antigen, Antiserum, Control
- LYRHelicobacter Pylori
- CZPIga, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- DHRSystem, Test, Rheumatoid Factor
- DDGTransferrin, Antigen, Antiserum, Control
- EGDWax, Dental, Intraoral
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain