Cobas-Fp TDM Calibration Verification Test Set
FDA 510(k) K962165 · Roche Diagnostic Systems, Inc.
510(k) numberK962165
Submission
- Device name
- Cobas-Fp TDM Calibration Verification Test Set
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- June 4, 1996
- Decision date
- June 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Cobas-Fp TDM Calibration Verification Test Set cleared by the FDA?
Cobas-Fp TDM Calibration Verification Test Set (K962165) received a 510(k) decision of Substantially Equivalent on June 26, 1996, 22 days after the submission was received.
What is the product code of K962165?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.