Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01
FDA 510(k) K080696 · Abbott Laboratories
510(k) numberK080696
Submission
- Device name
- Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- March 12, 2008
- Decision date
- September 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIP – Enzyme Immunoassay, Diphenylhydantoin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K063145 | Phenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol ControlsDIP · Traditional | Thermo Electron OY | 10/17/2007SE |
| K030428 | Roche Online TDM PhenytoinDIP · Traditional | Roche Diagnostics Corp. | 04/28/2003SE |
| K011393 | Randox PhenytoinDIP · Traditional | Randox Laboratories, Ltd. | 12/04/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | Syva Co. | 05/17/2001SE |
| K000006 | Immulite Phenytoin, Immulite 2000 Phenytoin, Catalog # LKPN1, LKPN5 & L2KPN2, L2KPN6DIP · Traditional | Diagnostic Products Corp. | 02/28/2000SE |
| K993026 | Abbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin CalibratorsDIP · Traditional | Syva Co. | 01/27/2000SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | Schiapparelli Biosystems, Inc. | 11/04/1997SE |
| K963840 | Cedia Phenytoin II AssayDIP · Traditional | Boehringer Mannheim Corp. | 11/20/1996SE |
| K943980 | Il Test Phenytion CalibratorsDIP · Traditional | Instrumentation Laboratory CO | 05/01/1995SE |
| K945725 | Phenytion Eia TestDIP · Traditional | Diagnostic Reagents, Inc. | 02/03/1995SE |
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Questions and answers
When was Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01 cleared by the FDA?
Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and 1P34-01 (K080696) received a 510(k) decision of Substantially Equivalent on September 11, 2008, 183 days after the submission was received.
What is the product code of K080696?
The FDA product code is DIP – Enzyme Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.