FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
K Number: K880823
·
Decision May 31, 1988
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
84
Applicant Total
94
Review Days
91
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
- AMERLITE DIGOXIN ASSAY, LAN.0700/2700, 240/144 KIT
- K Number
- K880823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3320
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Amersham Corp.
- Date Received
- March 1, 1988
- Decision Date
- May 31, 1988
- 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 Amersham Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | Feb 18, 1992 | Substantially Equivalent |
| K912733 | AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT | Jul 22, 1991 | Substantially Equivalent |
| K912766 | AMERLITE CK-MB ASSAY | Jul 17, 1991 | Substantially Equivalent |
| K904666 | AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 | Nov 2, 1990 | Substantially Equivalent |
| K902760 | AMERSHAM TSH CONTROL SERA | Jul 27, 1990 | Substantially Equivalent |
| K901854 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10411/10412) | Jul 9, 1990 | Substantially Equivalent |
| K901857 | GADOLINIUM-153 BONE DENSITOMETER (GDC.10413) | Jul 9, 1990 | Substantially Equivalent |
| K901848 | GADOLINIUM-153 BONE DENSITOMETER SOURCES | Jul 9, 1990 | Substantially Equivalent |
| K901832 | GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 | Jul 9, 1990 | Substantially Equivalent |
| K896270 | AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081 | Dec 12, 1989 | Substantially Equivalent |