Genesis RMP
FDA 510(k) K963268 · Tecan U.S., Inc.
510(k) numberK963268
Submission
- Device name
- Genesis RMP
- Applicant
- Tecan U.S., Inc.
Research Triangle Park, NC, US - Received
- August 20, 1996
- Decision date
- March 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JRA – Microtitrator, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2680
- Specialty
- Clinical Chemistry
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| K953345 | GenesisJQW · Traditional | 11/21/1995SE |
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| K942655 | 4 Channel DispenserJQW · Traditional | 09/02/1994SE |
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| K915492 | RSP Mega Sample ProcessorJQW · Traditional | 02/21/1992SE |
| K912036 | Robotic Sample ProcessorJQW · Traditional | 07/26/1991SE |
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| K894126 | Robotic Sample ProcessorJQW · Traditional | 08/15/1989SE |
| K854406 | Tecan Robotic Sample Processor(Rsp) #500JQW · Traditional | 02/10/1986SE |
Questions and answers
When was Genesis RMP cleared by the FDA?
Genesis RMP (K963268) received a 510(k) decision of Substantially Equivalent on March 18, 1997, 210 days after the submission was received.
What is the product code of K963268?
The FDA product code is JRA – Microtitrator, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2680.