510(k) K811212
- Device
- DIGOXIN (RIA) KIT
- Applicant
- IMMUNO ASSAY CORP.
- 510(k) number
- K811212
- Product code
- DNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-05-21
- Date received
- 1981-05-04
- Regulation
- 862.3320
- Classification name
- Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Second 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 DNL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K852343 | DIG RADIOIMMUNOASSAY TEST SYSTEM | M Nobird, Inc. | 1985-07-09 |
| K852291 | TIPSEP DIGOXIN RIA | Nuclear Diagnostics, Inc. | 1985-06-25 |
| K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | E. R. Squibb & Sons, Inc. | 1981-04-21 |
| K802841 | DIGOXIN RADIOIMMUNOASSAY KIT | American Diagnostic Corp. | 1980-12-18 |
| K781834 | TEST SET, 125 I-DIGOXIN | Wien Laboratories, Inc. | 1979-01-03 |
| K781495 | RIANEN ASSAY SYSTEM, 125I KIT | New England Nuclear | 1978-09-14 |
| K772110 | IN VITRO DIGOXIN RIA TEST | Clinical Assays, Inc. | 1977-11-22 |
Legacy Summary#
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FDA Review#
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