FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
K Number: K904458
·
Decision Oct 12, 1990
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
79
Applicant Total
12
Review Days
11
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Basic Information
- Device Name
- LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION
- K Number
- K904458
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1625
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- London Diagnostics, Inc.
- Date Received
- October 1, 1990
- Decision Date
- October 12, 1990
- Product Code
- CFT
- 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 |
|---|---|---|---|
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 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 |
| K905814 | LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY | Feb 4, 1991 | 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 |