Fiax Test Kit for Mumps-G Antibodies
FDA 510(k) K872733 · Whittaker Bioproducts, Inc.
510(k) numberK872733
Submission
- Device name
- Fiax Test Kit for Mumps-G Antibodies
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- July 9, 1987
- Decision date
- October 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GRB – Antiserum, Cf, Mumps Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3380
- Specialty
- Microbiology
Other 510(k)s with product code GRB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872699 | Mumps CF Antigen and Control AntigenGRB · Traditional | Sita, Inc. | 09/18/1987SE |
More from Sita, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K911356 | Legionella Stat Igg/Igm Test KitMJH · Traditional | 07/30/1992SE |
| K913212 | 3M Ige Single Point Fast TestDHB · Traditional | 11/22/1991SE |
| K904652 | Lyme Stat M Test KitLSR · Traditional | 10/21/1991SE |
| K904893 | Fiax Lyme M Test KitLSR · Traditional | 10/16/1991SE |
| K911473 | Ebna Stat Test KitLLM · Traditional | 09/25/1991SE |
| K905468 | Pylori-G Fiax Test KitLYR · Traditional | 05/07/1991SE |
| K904738 | Pylori Stat Test KitLYR · Traditional | 05/07/1991SE |
| K901493 | Fitc Murine Monoclonal Anti-Influenza Type BGNX · Traditional | 06/27/1990SE |
| K893579 | Fitc Murine Monoclonal Anti-Influenza Type aGNX · Traditional | 01/16/1990SE |
| K894932 | Fiax Eb Vca-M Test KitLSE · Traditional | 10/16/1989SE |
Questions and answers
When was Fiax Test Kit for Mumps-G Antibodies cleared by the FDA?
Fiax Test Kit for Mumps-G Antibodies (K872733) received a 510(k) decision of Substantially Equivalent on October 6, 1987, 89 days after the submission was received.
What is the product code of K872733?
The FDA product code is GRB – Antiserum, Cf, Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.