Ace Cedia Phenobarbital Assay
FDA 510(k) K942501 · Schiapparelli Biosystems, Inc.
510(k) numberK942501
Submission
- Device name
- Ace Cedia Phenobarbital Assay
- Applicant
- Schiapparelli Biosystems, Inc.
Columbia, MD, US - Received
- May 24, 1994
- Decision date
- October 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DLZ – Enzyme Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210858 | VITROS Chemistry Products PHBR SlidesDLZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 08/13/2021SE |
| K123271 | Abbott Phenobarbital AssayDLZ · Traditional | Microgenics Corp. | 04/26/2013SE |
| K081231 | Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…DLZ · Traditional | Abbott Laboratories | 09/26/2008SE |
| K071644 | Online Phenobarbital, Model 03016757190 & 03510620DLZ · Traditional | Roche Diagnostics Corp. | 09/12/2007SE |
| K011303 | Randox PhenobarbitalDLZ · Traditional | Randox Laboratories, Ltd. | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | Syva Co. | 06/06/2001SE |
| K000012 | Immulite Phenobarbital, Models LKPB1, LKPB5DLZ · Traditional | Diagnostic Products Corp. | 03/03/2000SE |
| K993031 | Abbott Aeroset Phenobarbital Assey and Calibrators;Models 1E08 and 5F54DLZ · Traditional | Syva Co. | 01/27/2000SE |
| K984288 | Vitros Chemistry Products PHBR SlidesDLZ · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/26/1999SE |
| K946210 | Phenobarbital Enzyme ImmunoassayDLZ · Traditional | Diagnostic Reagents, Inc. | 02/10/1995SE |
More from Diagnostic Reagents, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991733 | Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C ControlsMRR · Traditional | 07/13/1999SE |
| K981377 | Ace T4 Reagent T4 CalibratorsKLI · Traditional | 06/10/1998SE |
| K981375 | Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional | 06/10/1998SE |
| K973583 | Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional | 11/12/1997SE |
| K973582 | Ace Primidone Reagent, AED CalibratorsDJD · Traditional | 11/12/1997SE |
| K973581 | Ace Valproic Acid Reagent, AED CalibratorsLEG · Traditional | 11/12/1997SE |
| K973536 | Ace Phenobarbital Reagent/Aed CalibratorsDLJ · Traditional | 11/06/1997SE |
| K973414 | Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional | 11/04/1997SE |
| K973535 | Ace Carbamazepine Reagent/Aed CalibratorsKLT · Traditional | 10/20/1997SE |
| K971526 | Ace Hdl-C ReagentLBS · Traditional | 05/21/1997SE |
Questions and answers
When was Ace Cedia Phenobarbital Assay cleared by the FDA?
Ace Cedia Phenobarbital Assay (K942501) received a 510(k) decision of Substantially Equivalent on October 6, 1994, 135 days after the submission was received.
What is the product code of K942501?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.