Modification to N/T Rheumatology Controls SL 1 & 2
FDA 510(k) K021381 · Dade Behring, Inc.
510(k) numberK021381
Submission
- Device name
- Modification to N/T Rheumatology Controls SL 1 & 2
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- May 1, 2002
- Decision date
- June 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Modification to N/T Rheumatology Controls SL 1 & 2 cleared by the FDA?
Modification to N/T Rheumatology Controls SL 1 & 2 (K021381) received a 510(k) decision of Substantially Equivalent on June 10, 2002, 40 days after the submission was received.
What is the product code of K021381?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.