Emit 2000 Phenytoin Assay, Model 0SR4A229
FDA 510(k) K011347 · Syva Co.
510(k) numberK011347
Submission
- Device name
- Emit 2000 Phenytoin Assay, Model 0SR4A229
- Applicant
- Syva Co.
San Jose, CA, US - Received
- May 2, 2001
- Decision date
- May 17, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| K080696 | Architect Iphenytoin Reagents and Architech Iphenytoin Calibrators with Models 1P34, and…DIP · Traditional | Abbott Laboratories | 09/11/2008SE |
| 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 |
| 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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| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
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| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
| K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULJXM · Traditional | 01/27/2000SE |
Questions and answers
When was Emit 2000 Phenytoin Assay, Model 0SR4A229 cleared by the FDA?
Emit 2000 Phenytoin Assay, Model 0SR4A229 (K011347) received a 510(k) decision of Substantially Equivalent on May 17, 2001, 15 days after the submission was received.
What is the product code of K011347?
The FDA product code is DIP – Enzyme Immunoassay, Diphenylhydantoin, a Class II (moderate risk) device regulated under 21 CFR 862.3350.