DLZ — Enzyme Immunoassay, Phenobarbital Class II
FDA product code DLZ covers "Enzyme Immunoassay, Phenobarbital", a Class II medical device regulated under 21 CFR 862.3660. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DLZ
- Device Class
- Class II
- Regulation Number
- 862.3660
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K210858 | ortho-clinical diagnostics | VITROS Chemistry Products PHBR Slides | August 13, 2021 |
| K123271 | microgenics | ABBOTT PHENOBARBITAL ASSAY | April 26, 2013 |
| K081231 | abbott laboratories | ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODE | September 26, 2008 |
| K071644 | roche diagnostics | ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 | September 12, 2007 |
| K011303 | randox laboratories | RANDOX PHENOBARBITAL | July 2, 2001 |
| K011528 | syva | EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 | June 6, 2001 |
| K000012 | diagnostic products | IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 | March 3, 2000 |
| K993031 | syva | ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS;MODELS 1E08 AND 5F54 | January 27, 2000 |
| K984288 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS PHBR SLIDES | January 26, 1999 |
| K946210 | diagnostic reagents | PHENOBARBITAL ENZYME IMMUNOASSAY | February 10, 1995 |
| K943981 | instrumentation laboratory | IL TEST PHENOBARBITAL CALIBRATORS | January 18, 1995 |
| K944932 | dupont medical products | PHENOBARBITAL FLEX REAGENT CARTRIDGE | December 28, 1994 |
| K942501 | schiapparelli biosystems | ACE CEDIA PHENOBARBITAL ASSAY | October 6, 1994 |
| K935568 | baxter diagnostics | PARAMAX PHENOBARBITAL REAGENT AND CALIBRATORS | March 11, 1994 |
| K913190 | syva | EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS | August 26, 1991 |
| K910355 | instrumentation laboratory | IL PHENOBARBITAL ASSAY SYSTEM | April 3, 1991 |
| K896861 | pb diagnostic systems | OPUS PHENOBARBITAL TEST SYSTEM | January 11, 1990 |
| K884419 | technicon instruments | TECHNICON RA-PHENOBARBITAL | November 22, 1988 |
| K874625 | syva | EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY | December 22, 1987 |
| K864926 | em diagnostic systems | EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 | January 7, 1987 |