FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMMPULSE DIGOXIN ASSAY REAGENTS
K Number: K874748
·
Decision Feb 19, 1988
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
14
Applicant Total
82
Review Days
93
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Basic Information
- Device Name
- IMMPULSE DIGOXIN ASSAY REAGENTS
- K Number
- K874748
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- November 18, 1987
- Decision Date
- February 19, 1988
- Product Code
- LCS
- 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 |
|---|---|---|---|
| LCS | Radioimmunoassay, Digoxin (125-I) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCS), ordered by most recent decision date.
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FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT
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DART DIGOXIN ASSAY
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TDX DIGOXIN
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Sclavo, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914789 | ELISA CMV IGM | Mar 4, 1992 | Substantially Equivalent |
| K914852 | ELISA TOXO IGM | Jan 23, 1992 | Substantially Equivalent |
| K914420 | ELISA RUBELLA IGM | Dec 27, 1991 | Substantially Equivalent |
| K895943 | NORMAL AND ABNORMAL CONTROL SERA | Dec 27, 1989 | Substantially Equivalent |
| K895822 | TOTAL BILIRUBIN L.F. | Nov 14, 1989 | Substantially Equivalent |
| K895847 | CREATININE 340 (ENZYMATIC) | Oct 30, 1989 | Substantially Equivalent |
| K880049 | CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K880199 | CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE | Jan 27, 1989 | Substantially Equivalent |
| K873496 | ATYPICAL CHOLINESTERASE | Jan 27, 1989 | Substantially Equivalent |
| K884035 | SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER | Dec 29, 1988 | Substantially Equivalent |