Bio-Tek El 401 Handheld Microplate Washer
FDA 510(k) K853920 · Bio-Tek Instruments, Inc.
510(k) numberK853920
Submission
- Device name
- Bio-Tek El 401 Handheld Microplate Washer
- Applicant
- Bio-Tek Instruments, Inc.
Burlington, VT, US - Received
- September 23, 1985
- Decision date
- October 22, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTC – Device, Microtiter Diluting/Dispensing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2500
- Specialty
- Microbiology
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| K891766 | Genetic Systems Microplate Strip WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
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| K884695 | Washer 500 Microelisa SystemJTC · Traditional | Organon Teknika Corp. | 12/13/1988SE |
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Questions and answers
When was Bio-Tek El 401 Handheld Microplate Washer cleared by the FDA?
Bio-Tek El 401 Handheld Microplate Washer (K853920) received a 510(k) decision of Substantially Equivalent on October 22, 1985, 29 days after the submission was received.
What is the product code of K853920?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.