FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RABBIT ANTIBODY TO DIGOXIN
K Number: K780316
·
Decision Mar 17, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
29
Review Days
21
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Basic Information
- Device Name
- RABBIT ANTIBODY TO DIGOXIN
- K Number
- K780316
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Pcl-Ria, Inc.
- Date Received
- February 24, 1978
- Decision Date
- March 17, 1978
- Product Code
- DKA
- 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 |
|---|---|---|---|
| DKA | Antiserum, Digoxin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DKA), ordered by most recent decision date.
STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CBR-DIGOXIN ANTISERUM
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Pcl-Ria, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830526 | B-GCG SYSTEM BY RIA | Apr 5, 1983 | Substantially Equivalent |
| K822935 | THYROID STIMULATING HORMONE | Nov 1, 1982 | Substantially Equivalent |
| K823014 | DIGOXIN KIT | Nov 1, 1982 | Substantially Equivalent |
| K822612 | T3 UPTAKE KITS | Sep 30, 1982 | Substantially Equivalent |
| K820886 | THYROXINE T4 KIT | Apr 16, 1982 | Substantially Equivalent |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | Mar 26, 1982 | Substantially Equivalent |
| K820357 | LUTEINIZING HORMONE KIT | Mar 25, 1982 | Substantially Equivalent |
| K812666 | THYROXINE (T4) 125I | Oct 2, 1981 | Substantially Equivalent |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | Apr 14, 1981 | Substantially Equivalent |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | Apr 8, 1981 | Substantially Equivalent |