Immunodot Mono-M Test
FDA 510(k) K974244 · Genbio
510(k) numberK974244
Submission
- Device name
- Immunodot Mono-M Test
- Applicant
- Genbio
San Diego, CA, US - Received
- November 12, 1997
- Decision date
- September 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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More from Panbio Limited
| 510(k) | Device | Decision |
|---|---|---|
| K010301 | Immunowell Ea (D) Igg TestLSE · Traditional | 06/11/2001SE |
| K974226 | Immunodot Mono-G TestLSE · Traditional | 09/22/1998SE |
| K973941 | Immunowell Ebna Igg TestLLM · Traditional | 08/10/1998SE |
| K973940 | Immunowell Ebv Vca Igg TestLSE · Traditional | 08/10/1998SE |
| K973939 | Immunowell Vca Igm TestLJN · Traditional | 08/10/1998SE |
| K963054 | Immunowell Mycoplasma Pneumonia Antibody (Igm) Test (3130)LJZ · Traditional | 05/05/1997SE |
| K963055 | Immunowell Mycoplasma Pneumonia Antibody (Igg) Test 3120LJZ · Traditional | 05/02/1997SE |
| K953683 | Mmuno Dot Borrelia Dot Blot M TestLSR · Traditional | 05/03/1996SE |
| K953682 | Immuno Dot Borrelia Dot Blot G TestLSR · Traditional | 05/03/1996SE |
Questions and answers
When was Immunodot Mono-M Test cleared by the FDA?
Immunodot Mono-M Test (K974244) received a 510(k) decision of Substantially Equivalent on September 22, 1998, 314 days after the submission was received.
What is the product code of K974244?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.