FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
K Number: K905814
·
Decision Feb 4, 1991
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
87
Applicant Total
12
Review Days
38
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Basic Information
- Device Name
- LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY
- K Number
- K905814
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- London Diagnostics, Inc.
- Date Received
- December 28, 1990
- Decision Date
- February 4, 1991
- Product Code
- CGJ
- 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 |
|---|---|---|---|
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | FDA class 1 | Clinical Chemistry |
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Other Clearances by London Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K914835 | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY | Dec 17, 1991 | Substantially Equivalent |
| K911985 | LUMATAG T4 CHEMILUMINESCENCE ASSAY | Aug 2, 1991 | Substantially Equivalent |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | Jul 30, 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 |