FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RIANEN LUTEINIZING HORMONE RIA KIT
K Number: K833376
·
Decision Dec 20, 1983
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
18
Review Days
83
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
- RIANEN LUTEINIZING HORMONE RIA KIT
- K Number
- K833376
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- New England Nuclear
- Date Received
- September 28, 1983
- Decision Date
- December 20, 1983
- Product Code
- CEP
- 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEP), ordered by most recent decision date.
MAYBE?MOM MINI OVULATION MICROSCOPE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INSTANT-VIEW LH OVULATION PREDICTING TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
AT HOME OVULATION TEST, MODEL 9032
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLEARPLANE EASY OVULATION TEST
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TCI-31 LIFELONG OVULATION TESTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
QUIK-CHECK OVULATION PREDICTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by New England Nuclear
| K Number | Device Name | ||
|---|---|---|---|
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | Jun 14, 1984 | Substantially Equivalent |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | Mar 30, 1984 | Substantially Equivalent |
| K834038 | RIANEN FOLLICLE STIMULATING HORMONE | Jan 30, 1984 | Substantially Equivalent |
| K831345 | RIANEN PROLACTIN 125I KIT | Jun 8, 1983 | Substantially Equivalent |
| K801245 | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION | Jun 20, 1980 | Substantially Equivalent |
| K792175 | RIANEN, VITAMIN B12 ASSAY SYSTEM | Nov 13, 1979 | Substantially Equivalent |
| K790817 | RIA KIT, QUANTITATION OF PROSTATIC ACID | May 7, 1979 | Substantially Equivalent |
| K782110 | RIA KIT, RIANEN CORTISOL | Jan 26, 1979 | Substantially Equivalent |
| K781888 | ASSAY SYSTEM, FERRITIN I KIT | Jan 10, 1979 | Substantially Equivalent |
| K781495 | RIANEN ASSAY SYSTEM, 125I KIT | Sep 14, 1978 | Substantially Equivalent |