N/T Rheumatology Control SL/1, SL/2
FDA 510(k) K944375 · Behring Diagnostics, Inc.
510(k) numberK944375
Submission
- Device name
- N/T Rheumatology Control SL/1, SL/2
- Applicant
- Behring Diagnostics, Inc.
Westwood, MA, US - Received
- September 7, 1994
- Decision date
- October 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was N/T Rheumatology Control SL/1, SL/2 cleared by the FDA?
N/T Rheumatology Control SL/1, SL/2 (K944375) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 26 days after the submission was received.
What is the product code of K944375?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.