Validate TDM Calibration Verification Test Set, Model 126
FDA 510(k) K033879 · Maine Standards Co.
510(k) numberK033879
Submission
- Device name
- Validate TDM Calibration Verification Test Set, Model 126
- Applicant
- Maine Standards Co.
Windham, ME, US - Received
- December 15, 2003
- Decision date
- February 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKB – Calibrators, Drug Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| K090900 | Advia Chemistry Drug Calibrator II, Model 10376771DKB · Abbreviated | Siemens Healthcare Diagnostics | 06/01/2009SE |
| K062162 | Dimension Vista System Drugs of Abuse Calibrator (Udat Cal - KC510)DKB · Traditional | Dade Behring, Inc. | 09/14/2006SE |
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| K060645 | Preciset Dat Plus I, Preciset Dat Plus II and Cfas Dat Qualitative Plus CalibratorsDKB · Abbreviated | Roche Diagnostics Corp. | 05/30/2006SE |
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Questions and answers
When was Validate TDM Calibration Verification Test Set, Model 126 cleared by the FDA?
Validate TDM Calibration Verification Test Set, Model 126 (K033879) received a 510(k) decision of Substantially Equivalent on February 27, 2004, 74 days after the submission was received.
What is the product code of K033879?
The FDA product code is DKB – Calibrators, Drug Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.3200.