FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MATCHED COMPONENT SET FOR DIGITOXIN
K Number: K834080
·
Decision Feb 4, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
14
Review Days
68
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
- MATCHED COMPONENT SET FOR DIGITOXIN
- K Number
- K834080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3300
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Cambridge Medical Technology
- Date Received
- November 28, 1983
- Decision Date
- February 4, 1984
- Product Code
- LCW
- 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 |
|---|---|---|---|
| LCW | Radioimmunoassay, Digitoxin (125-I) | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCW), ordered by most recent decision date.
ENDAB DIGITOXIN ENZYME IMMUNOASSAY KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
(125 I) DIGITOXIN RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Cambridge Medical Technology
| K Number | Device Name | ||
|---|---|---|---|
| K890837 | RIA-GNOST INSULIN | Apr 26, 1989 | Substantially Equivalent |
| K890836 | RIA-GNOST PROGESTERONE | Mar 16, 1989 | Substantially Equivalent |
| K890697 | RIA-GNOST FERRITIN | Mar 16, 1989 | Substantially Equivalent |
| K873737 | NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAY | Nov 24, 1987 | Substantially Equivalent |
| K870573 | T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT | Apr 22, 1987 | Substantially Equivalent |
| K862871 | RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL | Aug 19, 1986 | Substantially Equivalent |
| K860130 | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT | Feb 19, 1986 | Substantially Equivalent |
| K855169 | T3 UPTAKE RADIOIMMUNOASSAY KIT | Feb 6, 1986 | Substantially Equivalent |
| K850254 | PARATHYROID HORMONE RADIOIMMUNOASSAY KIT | Apr 3, 1985 | Substantially Equivalent |
| K843635 | MATCHED COMPONENT SET FOR RADIOIMMUNO- | Sep 28, 1984 | Substantially Equivalent |