Panels › Microbiology › Product code GON · Class 2
Antigen, Cf (Including Cf Control), Rubella
Regulation 866.3510
0510(k)s in 12 months (5 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GON
| Company | 510(k)s | Recalls |
|---|---|---|
| Orion Diagnostica, Inc. | 2 | 0 |
| Microbiological Assoc. | 1 | 0 |
| Microbix Biosystems, Inc. | 1 | 0 |
| Syva Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 1989 | K894262 | RUBELLA ANTIGEN AND CONTROL ANTIGEN Microbix Biosystems, Inc. | GON |
| Feb 4, 1988 | K880157 | MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST Syva Co. | GON |
| Dec 31, 1980 | K802939 | HERPES SIMPLEX TYPE I Orion Diagnostica, Inc. | GON |
| Dec 31, 1980 | K802937 | RUBELLA VIRUS ANTIGENS & CONTROLS Orion Diagnostica, Inc. | GON |
| Nov 22, 1978 | K780996 | RUBELISA TEST KIT Microbiological Assoc. | GON |
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