Company ยท US
Orion Diagnostica, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2016. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 3 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 2 |
| GON | Antigen, Cf (Including Cf Control), Rubella | 2 |
| CIN | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes | 1 |
| CZP | Iga, Antigen, Antiserum, Control | 1 |
| DAH | Gamma Globulin, Antigen, Antiserum, Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 |
| EGD | Wax, Dental, Intraoral | 1 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 |
| GRC | Antigen, Cf (Including Cf Control), Mumps Virus | 1 |
| GRJ | Antigen, Cf, (Including Cf Control), Rubeola | 1 |
| GSB | Antigens, Cf, All, Mycoplasma Spp. | 1 |
| GTY | Antigens, All Groups, Streptococcus Spp. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2016 | K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument Orion Diagnostica, OY, FI | DCK |
| May 4, 2005 | K043125 | ORION DIAGNOSTICA UNIQ PINP RIA Orion Diagnostica, OY, FI | CIN |
| Nov 18, 2004 | K042625 | QUIKREAD CRP CALIBRATOR SET Orion Diagnostica, OY, FI | JJY |
| Sep 24, 2004 | K042442 | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE Orion Diagnostica, OY, FI | DCK |
| Dec 14, 1994 | K942286 | DIARLEX ROTA-ADENO Orion Diagnostica, Inc., FI | LIQ |
| Sep 2, 1992 | K914892 | SALIVA-STIM Orion Diagnostica, Inc., FI | EGD |
| Oct 21, 1991 | K904655 | PYLORISET Orion Diagnostica, Inc., FI | LYR |
| Oct 27, 1988 | K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M Orion Diagnostica, Inc., FI | DFT |
| Oct 27, 1988 | K884074 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G Orion Diagnostica, Inc., FI | DAH |
| Oct 19, 1988 | K884075 | IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN Orion Diagnostica, Inc., FI | DDG |
| Oct 19, 1988 | K884040 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN A Orion Diagnostica, Inc., FI | CZP |
| Jun 4, 1987 | K864645 | ADENOLEX (R) LATEX AGGLUTINATION TEST Orion Diagnostica, Inc. | GOD |
| May 6, 1987 | K871196 | RHEUMA-CHECK ENZYME IMMUNOASSAY TEST Orion Diagnostica, Inc. | DHR |
| Sep 16, 1986 | K862475 | RESPIRASTICK ENZYME IMMUNOASSAY TEST Orion Diagnostica, Inc. | GTY |
| Jan 21, 1986 | K854129 | ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS Orion Diagnostica, Inc. | LIQ |
| Jan 8, 1985 | K844399 | RESPIRALEX LATEX AGGLUTINATION TEST Orion Diagnostica, Inc. | GTZ |
| Sep 14, 1984 | K841319 | ROTALEX LATEX AGGLUTINATION TEST Orion Diagnostica, Inc. | LIQ |
| May 9, 1983 | K831124 | BIOCULT - GC CULTURE-PADDLES Orion Diagnostica, Inc. | JTY |
| Aug 5, 1982 | K821659 | RESPIRACULT-STREP DEEP BED CULTURE PAD Orion Diagnostica, Inc. | JSH |
| Jan 12, 1981 | K802931 | INFLUENZA A & B S-ANTIGEN & CONTROLS Orion Diagnostica, Inc. | GNX |
| Jan 9, 1981 | K802930 | CYTOMEGALO VIRUS & CONTROLS Orion Diagnostica, Inc. | GQH |
| Dec 31, 1980 | K802939 | HERPES SIMPLEX TYPE I Orion Diagnostica, Inc. | GON |
| Dec 31, 1980 | K802938 | VARICELLA-ZOSTER ANTIGENS & CONTROLS Orion Diagnostica, Inc. | GQW |
| Dec 31, 1980 | K802937 | RUBELLA VIRUS ANTIGENS & CONTROLS Orion Diagnostica, Inc. | GON |
| Dec 31, 1980 | K802936 | RESPIRATORY SYNCYTIAL VIRUS ANTIGEN & Orion Diagnostica, Inc. | GQG |
| Dec 31, 1980 | K802935 | PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR Orion Diagnostica, Inc. | GQS |
| Dec 31, 1980 | K802934 | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL Orion Diagnostica, Inc. | GSB |
| Dec 31, 1980 | K802933 | MUMPS S & V ANTIGENS & CONTROLS Orion Diagnostica, Inc. | GRC |
| Dec 31, 1980 | K802932 | MEASLES VIRUS & CONTROLS Orion Diagnostica, Inc. | GRJ |
| Dec 31, 1980 | K802929 | ADENO VIRUS & CONTROLS Orion Diagnostica, Inc. | GOD |
| Dec 22, 1980 | K802947 | ORICULT DTM Orion Diagnostica, Inc. | JSI |
| Dec 22, 1980 | K802946 | MYCOLOGY CULTURE SYSTEM Orion Diagnostica, Inc. | JSJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||