Roche-Tdm Onlein(Tm) Controls
FDA 510(k) K946119 · Roche Diagnostic Systems, Inc.
510(k) numberK946119
Submission
- Device name
- Roche-Tdm Onlein(Tm) Controls
- Applicant
- Roche Diagnostic Systems, Inc.
Somerville, NJ, US - Received
- December 15, 1994
- Decision date
- February 7, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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Questions and answers
When was Roche-Tdm Onlein(Tm) Controls cleared by the FDA?
Roche-Tdm Onlein(Tm) Controls (K946119) received a 510(k) decision of Substantially Equivalent on February 7, 1995, 54 days after the submission was received.
What is the product code of K946119?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.