FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
K Number: K831177
·
Decision May 17, 1983
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
149
Review Days
36
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Basic Information
- Device Name
- STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM-
- K Number
- K831177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- American Dade
- Date Received
- April 11, 1983
- Decision Date
- May 17, 1983
- Product Code
- KXT
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- IM
- 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 |
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Other Clearances by American Dade
| K Number | Device Name | ||
|---|---|---|---|
| K873051 | STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY | Oct 20, 1987 | Substantially Equivalent |
| K873171 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 29, 1987 | Substantially Equivalent |
| K873052 | STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY | Sep 14, 1987 | Substantially Equivalent |
| K872789 | PARAMAX URINE/CSF CALIBRATOR | Sep 2, 1987 | Substantially Equivalent |
| K872195 | DATA-FI DIMERTEST LATEX ASSAY | Aug 6, 1987 | Substantially Equivalent |
| K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III | Jul 31, 1987 | Substantially Equivalent |
| K871972 | STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY | Jul 21, 1987 | Substantially Equivalent |
| K871977 | DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR | Jul 9, 1987 | Substantially Equivalent |
| K872050 | PARAMAX CHOLESTEROL REAGENT | Jul 7, 1987 | Substantially Equivalent |
| K872360 | DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET | Jul 6, 1987 | Substantially Equivalent |