510(k) K110726
- Device
- ROCHE ACETAMINOPHEN ASSAY
- Applicant
- Roche Diagnostics
- 510(k) number
- K110726
- Product code
- LDP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-23
- Date received
- 2011-03-16
- Regulation
- 862.3030
- Classification name
- Colorimetry, Acetaminophen
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANGELO PEREIRA
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 8020316
- 3006198300
- 3005360469
- 3003795116
- 2050012
- 3005333358
- 2432235
- 9610529
- 1319809
- 3012963943
- 2250051
- 3010939897
- 2517506
- 3002642396
- 3017101757
- 2050010
- 3010825766
- 1616487
- 9610126
- 1319681
- 3000308930
Source Documents#
Other 510(k) Records For Product Code LDP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K202644 | Acetaminophen | Sekisui Diagnostics P.E.I., Inc. | 2022-02-18 |
| K180835 | SEKURE Acetaminophen L3K Assay | Sekisui Diagnostics P.E.I., Inc. | 2019-02-08 |
| K100200 | ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138 | Siemens Healthcare Diagnostics | 2010-08-02 |
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | Genzyme Diagnostics P.E.I., Inc. | 2009-05-01 |
| K061655 | DIMENSION VISTA FLEX REAGENT CARTRIDGES | Dade Behring, Inc. | 2006-07-10 |
| K043242 | TRIAGE TOX DRUG SCREEN | Biosite Incorporated | 2005-02-28 |
| K042330 | ACETAMINOPHEN-SL ASSAY | Diagnostic Chemicals , Ltd. | 2005-01-07 |
| K020792 | ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-07-11 |
| K013757 | ROCHE ACETAMINOPHEN | Roche Diagnostics Corp. | 2002-01-08 |
| K011465 | SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO | Beckman Coulter, Inc. | 2001-06-08 |
| K002974 | EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL; EMIT TOX ECETAMINOPHEN CALIBRATORS, MODEL 7A409UL | Dade Behring, Inc. | 2000-10-11 |
| K000494 | SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT | Beckman Coulter, Inc. | 2000-04-14 |
| K991598 | COBAS INTEGRA ACETAMINOPHEN | Roche Diagnostics Corp. | 1999-07-22 |
| K981059 | ACETAMINOPHEN-SL ASSAY, CATALOGUE # 505-10, 505-30. | Diagnostic Chemicals , Ltd. | 1998-05-12 |
| K980031 | ACETAMINOPHEN ASSAY (ACE), CATALOGUE NUMBER 503-10 | Diagnostic Chemicals , Ltd. | 1998-03-03 |
Legacy Summary#
summary
FDA Review#
Decision Summary