FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYME-TEST DIGOXIN
K Number: K823199
·
Decision Nov 29, 1982
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
48
Review Days
34
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
- ENZYME-TEST DIGOXIN
- K Number
- K823199
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Icl Scientific
- Date Received
- October 26, 1982
- Decision Date
- November 29, 1982
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| KXT | Enzyme Immunoassay, Digoxin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXT), ordered by most recent decision date.
ADVIA Centaur® Digoxin assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX DIGOXIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXSYM DIGOXIN III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Icl Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K883942 | HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL | Nov 10, 1988 | Substantially Equivalent |
| K843565 | KOVA TROL I,II, III HUMAN URINE-DRIED | Oct 5, 1984 | Substantially Equivalent |
| K833761 | THERAPEUTIC DRUG CONTROL | Jan 13, 1984 | Substantially Equivalent |
| K832823 | ENZYMUNE-TEST TSH | Oct 14, 1983 | Substantially Equivalent |
| K831383 | EVENT-TEST SLIDE | Jun 22, 1983 | Substantially Equivalent |
| K822346 | HISTIMUNE ENZYME-ANA TEST | Oct 8, 1982 | Substantially Equivalent |
| K822777 | THERAPEUTIC DRUG CONTROL | Oct 8, 1982 | Substantially Equivalent |
| K822465 | ENZYMUNE SYSTEM I | Sep 14, 1982 | Substantially Equivalent |
| K821374 | ENZYMUNE-TEST INSULIN | May 28, 1982 | Substantially Equivalent |
| K821097 | SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA | May 5, 1982 | Substantially Equivalent |