Universal 2 S Centrifuge
FDA 510(k) K843087 · Boehringer Mannheim Corp.
510(k) numberK843087
Submission
- Device name
- Universal 2 S Centrifuge
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- August 6, 1984
- Decision date
- August 29, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2050
- Specialty
- Clinical Chemistry
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Questions and answers
When was Universal 2 S Centrifuge cleared by the FDA?
Universal 2 S Centrifuge (K843087) received a 510(k) decision of Substantially Equivalent on August 29, 1984, 23 days after the submission was received.
What is the product code of K843087?
The FDA product code is JQC – Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2050.