FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
K Number: K914835
·
Decision Dec 17, 1991
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
12
Review Days
53
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
- LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY
- K Number
- K914835
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- London Diagnostics, Inc.
- Date Received
- October 25, 1991
- Decision Date
- December 17, 1991
- Product Code
- CEC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEC), ordered by most recent decision date.
Access Free T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys FT4 IV
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MAGLUMI 2000 FT4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elecsys FT4 III
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Abbott Architect Free T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FREND Free T4 Test System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by London Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | Aug 2, 1991 | Substantially Equivalent |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | Jul 30, 1991 | Substantially Equivalent |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | Feb 4, 1991 | Substantially Equivalent |
| K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION | Oct 12, 1990 | Substantially Equivalent |
| K903130 | LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY | Sep 25, 1990 | Substantially Equivalent |
| K902443 | LUMATAG(TM) LH DIAGNOSTIC KIT | Aug 2, 1990 | Substantially Equivalent |
| K903195 | LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY | Aug 2, 1990 | Substantially Equivalent |
| K901484 | LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC | May 1, 1990 | Substantially Equivalent |
| K901075 | LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. | Apr 2, 1990 | Substantially Equivalent |
| K881443 | LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY | May 27, 1988 | Substantially Equivalent |