510(k) K994093
- Device
- AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C
- Applicant
- PHAMATECH
- 510(k) number
- K994093
- Product code
- LCD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-12-16
- Date received
- 1999-12-03
- Regulation
- 862.3450
- Classification name
- Enzyme Immunoassay, Gentamicin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARL A MONGIOVI
- Address
- 9265 Activity Rd., #112-113 San Diego CA US 92126 92126
FDA Registration Numbers#
- 1832216
Source Documents#
Other 510(k) Records For Product Code LCD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243500 | ARCHITECT iGentamicin | Abbott Laboratories | 2025-07-09 |
| K102699 | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS | Abbott Laboratories | 2011-04-01 |
| K060709 | MULTIGENT GENTAMICIN | Seradyn, Inc. | 2006-06-15 |
| K042479 | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE | Ortho-Clinical Diagnostics, Inc. | 2005-01-06 |
| K020704 | ROCHE ONLINE GENTAMICIN | Roche Diagnostics Corp. | 2002-07-12 |
| K012978 | RANDOX GENTAMICIN | Randox Laboratories, Ltd. | 2001-09-18 |
| K012311 | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) | Diagnostic Products Corp. | 2001-08-20 |
| K010984 | EMIT 2000 GENTAMICIN PLUS ASSAY | Syva Co., Dade Behring, Inc. | 2001-04-20 |
| K962819 | GENTAMICIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 |
| K962519 | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS | Behring Diagnostics, Inc. | 1996-09-04 |
| K953020 | ACS GENTAMICIN | Ciba Corning Diagnostics Corp. | 1995-08-02 |
| K943982 | IL TEST GENTAMICIN CALIBRATORS | Instrumentation Laboratory CO | 1995-01-25 |
| K935376 | AXSYM GENTAMICIN | Abbott Mfg., Inc. | 1994-06-21 |
| K940376 | QMS GENTAMICIN ASSAY | Seradyn, Inc. | 1994-06-02 |
| K913470 | CEDIA(R) GENTAMICIN ASSAY | Microgenics Corp. | 1991-09-27 |
Legacy Summary#
summary
FDA Review#
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