Heating Block Microelisa System
FDA 510(k) K831642 · Organon Teknika Corp.
510(k) numberK831642
Submission
- Device name
- Heating Block Microelisa System
- Applicant
- Organon Teknika Corp.
Mchenry, IL, US - Received
- May 23, 1983
- Decision date
- July 26, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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Questions and answers
When was Heating Block Microelisa System cleared by the FDA?
Heating Block Microelisa System (K831642) received a 510(k) decision of Substantially Equivalent on July 26, 1983, 64 days after the submission was received.
What is the product code of K831642?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.