Company ยท US
Institute Virion , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1986. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 |
| GPS | Antigen, Cf, Q Fever | 1 |
| GPW | Antigen, Cf, Psittacosis (Chlamydia Group) | 1 |
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | 1 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 |
| GQW | Antigen, Cf, (Including Cf Control), Varicella-Zoster | 1 |
| GRJ | Antigen, Cf, (Including Cf Control), Rubeola | 1 |
| GSB | Antigens, Cf, All, Mycoplasma Spp. | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| JSJ | Culture Media, Selective And Non-Differential | 1 |
| LQP | Campylobacter Spp. | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 1986 | K862814 | COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNI Institute Virion , Ltd., CH | LQP |
| Sep 26, 1985 | K843676 | VARICELLA/ZOSTER VIRUS Institute Virion , Ltd. | GQW |
| Sep 26, 1985 | K843673 | RESPIRATORY SYNCYTIAL VIRUS Institute Virion , Ltd. | GQG |
| Sep 26, 1985 | K843667 | PARAINFLUENZA 3 Institute Virion , Ltd. | GQS |
| Sep 26, 1985 | K843665 | PARAINFLUENZA 1 Institute Virion , Ltd. | GQS |
| Sep 26, 1985 | K843662 | MEASLES VIRUS RUBEOLA Institute Virion , Ltd. | GRJ |
| Sep 26, 1985 | K843660 | IN FLUENZA B VIRUS Institute Virion , Ltd. | GNX |
| Sep 26, 1985 | K843659 | INFLUENZA A2 VIRUS Institute Virion , Ltd. | GNX |
| Sep 26, 1985 | K843658 | H. SIMPLEX VIRUS Institute Virion , Ltd. | GQN |
| Sep 26, 1985 | K843657 | CYTOMEGALOVIRUS Institute Virion , Ltd. | GQH |
| Sep 26, 1985 | K843649 | ADENOVIRUS Institute Virion , Ltd. | GOD |
| Aug 8, 1985 | K843672 | Q-FEVER Institute Virion , Ltd. | GPS |
| Aug 8, 1985 | K843654 | CHLAMYDIA Institute Virion , Ltd. | GPW |
| Oct 30, 1984 | K843668 | PHOTOMETER 90IYS Institute Virion , Ltd. | JJQ |
| Oct 25, 1984 | K843664 | MYCOPLASMA PNEUMONIAE Institute Virion , Ltd. | GSB |
| Oct 23, 1984 | K843653 | CAMPYLOCACTER SUPPLEMENT Institute Virion , Ltd. | JSJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||