510(k) K771533
- Device
- DIGOXIN RIA KIT
- Applicant
- G.D. SEARLE AND CO.
- 510(k) number
- K771533
- Product code
- DNJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-25
- Date received
- 1977-08-10
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-i), Goat Antibody, 2nd Antibody 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
Other 510(k) Records For Product Code DNJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K771877 | DIGOXIN RIA KIT | Antibodies, Inc. | 1977-10-21 |
Legacy Summary#
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FDA Review#
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