Pipette 12 Channel
FDA 510(k) K831644 · Organon Teknika Corp.
510(k) numberK831644
Submission
- Device name
- Pipette 12 Channel
- Applicant
- Organon Teknika Corp.
Mchenry, IL, US - Received
- May 23, 1983
- Decision date
- August 1, 1983
- 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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Questions and answers
When was Pipette 12 Channel cleared by the FDA?
Pipette 12 Channel (K831644) received a 510(k) decision of Substantially Equivalent on August 1, 1983, 70 days after the submission was received.
What is the product code of K831644?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.