FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K Number: K990251
·
Decision Mar 31, 1999
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
19
Applicant Total
343
Review Days
63
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
- K Number
- K990251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3300
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- January 27, 1999
- Decision Date
- March 31, 1999
- Product Code
- LFM
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFM | Enzyme Immunoassay, Digitoxin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LFM), ordered by most recent decision date.
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACS DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ABBOTT AXSYM DIGITOXIN (MODIFY)
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXSYM DIGITOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Dade Behring, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dec 20, 2010 | Substantially Equivalent |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | Jul 28, 2008 | Substantially Equivalent |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Jul 21, 2008 | Substantially Equivalent |
| K071603 | DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) | Jun 25, 2008 | Substantially Equivalent |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Jun 4, 2008 | Substantially Equivalent |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | Mar 13, 2008 | Substantially Equivalent |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | Feb 26, 2008 | Substantially Equivalent |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Feb 21, 2008 | Substantially Equivalent |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Jan 3, 2008 | Substantially Equivalent |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dec 21, 2007 | Substantially Equivalent |