Ebv/Ea-Check TM Test Kit
FDA 510(k) K903612 · Diagnostic Technology, Inc.
510(k) numberK903612
Submission
- Device name
- Ebv/Ea-Check TM Test Kit
- Applicant
- Diagnostic Technology, Inc.
Hauppauge, NY, US - Received
- August 9, 1990
- Decision date
- October 16, 1990
- 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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| 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 |
|---|---|---|
| K896378 | Lyme-Check(Tm) Test KitLSR · Traditional | 11/05/1991SE |
| K891542 | Ebna-Check(Tm) Test KitLLM · Traditional | 06/20/1989SE |
| K890819 | Hsv-Check(Tm) Test KitHIS · Traditional | 06/20/1989SE |
| K890639 | Resubmitted Ebv/Igm-Check Test KitLJN · Traditional | 06/20/1989SE |
| K871373 | Ebv-Check(Tm) Test Kit (Igg)GNP · Traditional | 06/25/1987SE |
| K864128 | Chlamydia-Check(Tm) Direct & Culture Confir. KitLJP · Traditional | 04/29/1987SE |
| K863408 | Ebv/Vca-Check(Tm) Antigen SlidesGNP · Traditional | 11/28/1986SE |
| K860586 | PHA-2 Conversion Program for Platelet AnalysisGKL · Traditional | 05/07/1986SE |
| K860166 | Picoscale Blood Cell Counter, Model PS-5GKL · Traditional | 04/04/1986SE |
| K853036 | Picoscale Laborscale, #PSL-1 & Analyser, #PSA-1GKL · Traditional | 11/05/1985SE |
Questions and answers
When was Ebv/Ea-Check TM Test Kit cleared by the FDA?
Ebv/Ea-Check TM Test Kit (K903612) received a 510(k) decision of Substantially Equivalent on October 16, 1990, 68 days after the submission was received.
What is the product code of K903612?
The FDA product code is LSE – Epstein-Barr Virus, Other, a Class I (low risk) device regulated under 21 CFR 866.3235.