LDP — Colorimetry, Acetaminophen Class II
FDA product code LDP covers "Colorimetry, Acetaminophen", a Class II medical device regulated under 21 CFR 862.3030. 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
- LDP
- Device Class
- Class II
- Regulation Number
- 862.3030
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K202644 | sekisui diagnostics p.e.i | Acetaminophen | February 18, 2022 |
| K180835 | sekisui diagnostics p.e.i | SEKURE Acetaminophen L3K Assay | February 8, 2019 |
| K110726 | roche diagnostics | ROCHE ACETAMINOPHEN ASSAY | December 23, 2011 |
| K100200 | siemens healthcare diagnostics | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | August 2, 2010 |
| K081938 | genzyme diagnostics p.e.i | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | May 1, 2009 |
| K061655 | dade behring | DIMENSION VISTA FLEX REAGENT CARTRIDGES | July 10, 2006 |
| K043242 | biosite incorporated | TRIAGE TOX DRUG SCREEN | February 28, 2005 |
| K042330 | diagnostic chemicals | ACETAMINOPHEN-SL ASSAY | January 7, 2005 |
| K020792 | bayer diagnostics | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | July 11, 2002 |
| K013757 | roche diagnostics | ROCHE ACETAMINOPHEN | January 8, 2002 |
| K011465 | beckman coulter | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO | June 8, 2001 |
| K002974 | dade behring | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, | October 11, 2000 |
| K000494 | beckman coulter | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | April 14, 2000 |
| K991598 | roche diagnostics | COBAS INTEGRA ACETAMINOPHEN | July 22, 1999 |
| K981059 | diagnostic chemicals | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | May 12, 1998 |
| K980031 | diagnostic chemicals | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | March 3, 1998 |
| K963244 | dade intl | ACETAMINOPHEN FLEX REAGENT CARTRIDGE | September 23, 1996 |
| K961373 | diagnostic reagents | ACETAMINOPHEN SERUM TOX EIA ASSAY | July 8, 1996 |
| K954933 | johnson and johnson clinical diagnostics | EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ACETAMINOPHEN | December 18, 1995 |
| K952949 | diagnostic chemicals | ACETAMINOPHEN ASSAY | September 6, 1995 |