Stat Test Kit for Eb-Vca Igg Antibody
FDA 510(k) K891086 · Whittaker Bioproducts, Inc.
510(k) numberK891086
Submission
- Device name
- Stat Test Kit for Eb-Vca Igg Antibody
- Applicant
- Whittaker Bioproducts, Inc.
Walkersville, MD, US - Received
- March 1, 1989
- Decision date
- May 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LSE – Epstein-Barr Virus, Other
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
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| K162961 | LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON®…LSE · Special | DiaSorin, Inc. | 01/05/2017SE |
| K162959 | LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetLSE · Special | DiaSorin, Inc. | 01/04/2017SE |
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | Quest Intl., Inc. | 06/08/2009SE |
| K073382 | Plexus Ebv Igg Multi-Analyte Diagnostics, Model: MP0500GLSE · Traditional | Focus Diagnostics, Inc. | 07/28/2008SE |
| K062213 | Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K062211 | Bioplex 2200 Ebv Igg Panel for Bioplex 2200 Multi-Analyte Detection SystemLSE · Traditional | Bio-Rad Laboratories, Inc. | 12/08/2006SE |
| K060204 | Liaison Ea IggLSE · Traditional | DiaSorin, Inc. | 10/18/2006SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | Quest Intl., Inc. | 01/16/2004SE |
| K030863 | Ebv VCA-P18 Igg ElisaLSE · Traditional | Panbio Limited | 06/27/2003SE |
More from Panbio Limited
| 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 Stat Test Kit for Eb-Vca Igg Antibody cleared by the FDA?
Stat Test Kit for Eb-Vca Igg Antibody (K891086) received a 510(k) decision of Substantially Equivalent on May 10, 1989, 70 days after the submission was received.
What is the product code of K891086?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.