Emit 2000 Phenobarbital Assay, Model OSR4D229
FDA 510(k) K011528 · Syva Co.
510(k) numberK011528
Submission
- Device name
- Emit 2000 Phenobarbital Assay, Model OSR4D229
- Applicant
- Syva Co.
San Jose, CA, US - Received
- May 17, 2001
- Decision date
- June 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
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| 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 |
| 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 |
| K943981 | Il Test Phenobarbital CalibratorsDLZ · Traditional | Instrumentation Laboratory CO | 01/18/1995SE |
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| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
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| K993985 | Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129ULJXM · Traditional | 01/27/2000SE |
Questions and answers
When was Emit 2000 Phenobarbital Assay, Model OSR4D229 cleared by the FDA?
Emit 2000 Phenobarbital Assay, Model OSR4D229 (K011528) received a 510(k) decision of Substantially Equivalent on June 6, 2001, 20 days after the submission was received.
What is the product code of K011528?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.