FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATUS THEOPHYLLINE ASSAY
K Number: K832965
·
Decision Dec 30, 1983
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
70
Applicant Total
149
Review Days
120
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Basic Information
- Device Name
- STRATUS THEOPHYLLINE ASSAY
- K Number
- K832965
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3880
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- American Dade
- Date Received
- September 1, 1983
- Decision Date
- December 30, 1983
- Product Code
- KLS
- 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 |
|---|---|---|---|
| KLS | Enzyme Immunoassay, Theophylline | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLS), ordered by most recent decision date.
VITROS CHEMISTRY PRODUCTS CAFFN REAGENT KIT AND TDM PERFORMANCE VERIFIERS I, II AND III
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ROCHE ONLINE THEOPHYLLINE
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RANDOX THEOPHYLLINE
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ACS: 180 AND ADVIA CENTAUR THEOPHYLLINE 2 ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
FDA 510(k)
FDA Class 2
·Clinical Toxicology
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 |