510(k) K760077
- Device
- TEST, RIA, SERUM DIGOXIN
- Applicant
- SMITH KLINE DIAGNOSTICS, INC.
- 510(k) number
- K760077
- Product code
- DND
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-07-16
- Date received
- 1976-06-18
- Regulation
- 862.3300
- Classification name
- Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Solid Phase Sep.
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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