Vista Antigen Brucella Melitensis
FDA 510(k) K972396 · Lee Laboratories, Inc.
510(k) numberK972396
Submission
- Device name
- Vista Antigen Brucella Melitensis
- Applicant
- Lee Laboratories, Inc.
Grayson, GA, US - Received
- June 26, 1997
- Decision date
- August 25, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GSO – Antigens (Febrile), Agglutination, Brucella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3085
- Specialty
- Microbiology
Other 510(k)s with product code GSO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972394 | Vista Antigen Brucella AbortusGSO · Traditional | Lee Laboratories, Inc. | 08/25/1997SE |
| K952139 | SAS Brucella Suis AntigenGSO · Traditional | Sa Scientific, Inc. | 07/18/1995SE |
| K952147 | SAS Brucella Abortus AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952140 | SAS Brucella Meltiensis AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952137 | SAS Salmonella H a AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952136 | SAS Salmonella H B AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952135 | SAS Salmonella H D AntigenGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K952131 | SAS Febrile Antigen SetGSO · Traditional | Sa Scientific, Inc. | 07/17/1995SE |
| K885112 | Brucella Ifa*GSO · Traditional | Investigacion Farmaceutica S.A. DE C.V. | 08/15/1989SE |
| K822663 | Febrile Antigen KitGSO · Traditional | Oxoid U.S.A., Inc. | 09/21/1982SE |
More from Oxoid U.S.A., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972395 | Vista Antigen Salmonella O Group DGNC · Traditional | 08/25/1997SE |
| K972394 | Vista Antigen Brucella AbortusGSO · Traditional | 08/25/1997SE |
| K972392 | Vista Antigen Salmonella H aGNC · Traditional | 08/25/1997SE |
| K972391 | Vista Antigen Salmonella H BGNC · Traditional | 08/25/1997SE |
| K972390 | Vista Antigen Salmonella H CGNC · Traditional | 08/25/1997SE |
| K972389 | Vista Antigen Salmonella H DGNC · Traditional | 08/25/1997SE |
| K972388 | Vista Antigen Salmonella O Group CGNC · Traditional | 08/25/1997SE |
| K972387 | Vista Antigen Salmonella O Group aGNC · Traditional | 08/25/1997SE |
| K972386 | Vista Antigen Salmonella O Group BGNC · Traditional | 08/25/1997SE |
Questions and answers
When was Vista Antigen Brucella Melitensis cleared by the FDA?
Vista Antigen Brucella Melitensis (K972396) received a 510(k) decision of Substantially Equivalent on August 25, 1997, 60 days after the submission was received.
What is the product code of K972396?
The FDA product code is GSO – Antigens (Febrile), Agglutination, Brucella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3085.