Online Phenobarbital, Model 03016757190 & 03510620
FDA 510(k) K071644 · Roche Diagnostics Corp.
510(k) numberK071644
Submission
- Device name
- Online Phenobarbital, Model 03016757190 & 03510620
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- June 15, 2007
- Decision date
- September 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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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|---|---|---|---|
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| K081231 | Architect Iphenobarbital Reagents and Architect Iphenobarbital Calibrators, Models 1P33…DLZ · Traditional | Abbott Laboratories | 09/26/2008SE |
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| K000012 | Immulite Phenobarbital, Models LKPB1, LKPB5DLZ · Traditional | Diagnostic Products Corp. | 03/03/2000SE |
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| 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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Questions and answers
When was Online Phenobarbital, Model 03016757190 & 03510620 cleared by the FDA?
Online Phenobarbital, Model 03016757190 & 03510620 (K071644) received a 510(k) decision of Substantially Equivalent on September 12, 2007, 89 days after the submission was received.
What is the product code of K071644?
The FDA product code is DLZ – Enzyme Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.