Vca Igm Elisa Test System
FDA 510(k) K980596 · Clark Laboratories, Inc.
510(k) numberK980596
Submission
- Device name
- Vca Igm Elisa Test System
- Applicant
- Clark Laboratories, Inc.
Frederick, MD, US - Received
- February 17, 1998
- Decision date
- July 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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| 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 |
|---|---|---|
| K980912 | Vca Igg Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | 05/01/1998SE |
| K973123 | Ea-D Igg Elisa Test SystemLSE · Traditional | 03/26/1998SE |
| K931543 | Encore Ena Combined EiaLLL · Traditional | 09/08/1993SE |
| K925826 | Encore Thyroglobulin Ige, Iga and Igm EiaJZO · Traditional | 01/26/1993SE |
| K923537 | Encore Ds-DnaLRM · Traditional | 12/23/1992SE |
| K921870 | Encore Sm/RnpLLL · Traditional | 12/01/1992SE |
| K921572 | Encore SMLLL · Traditional | 12/01/1992SE |
| K922340 | Encore Ss-BLLL · Traditional | 10/16/1992SE |
| K922157 | Encore Ss-ALLL · Traditional | 10/13/1992SE |
Questions and answers
When was Vca Igm Elisa Test System cleared by the FDA?
Vca Igm Elisa Test System (K980596) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 155 days after the submission was received.
What is the product code of K980596?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.