FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SRI DIGOXIN ENZYME IMMUNOASSAY
K Number: K915602
·
Decision Jan 17, 1992
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
23
Review Days
35
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
- SRI DIGOXIN ENZYME IMMUNOASSAY
- K Number
- K915602
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Serono-Baker Diagnostics, Inc.
- Date Received
- December 13, 1991
- Decision Date
- January 17, 1992
- Product Code
- KXT
- 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 |
|---|---|---|---|
| KXT | Enzyme Immunoassay, Digoxin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KXT), ordered by most recent decision date.
ADVIA Centaur® Digoxin assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
FDA 510(k)
FDA Class 2
·Clinical Toxicology
RANDOX DIGOXIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01
FDA 510(k)
FDA Class 2
·Clinical Toxicology
AXSYM DIGOXIN III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Serono-Baker Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY | Nov 30, 1992 | Substantially Equivalent |
| K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY | Mar 2, 1992 | Substantially Equivalent |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | Mar 2, 1992 | Substantially Equivalent |
| K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY | Nov 19, 1991 | Substantially Equivalent |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | Oct 23, 1991 | Substantially Equivalent |
| K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | Sep 18, 1991 | Substantially Equivalent |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | Aug 16, 1991 | Substantially Equivalent |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | Jul 25, 1991 | Substantially Equivalent |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | May 28, 1991 | Substantially Equivalent |
| K910837 | SRI TSH IMMUNENZYMETRIC ASSAY | May 24, 1991 | Substantially Equivalent |