FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LUTENIZING HORMONES
K Number: K810754
·
Decision Mar 31, 1981
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
29
Review Days
11
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
- LUTENIZING HORMONES
- K Number
- K810754
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pcl-Ria, Inc.
- Date Received
- March 20, 1981
- Decision Date
- March 31, 1981
- 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 Pcl-Ria, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830526 | B-GCG SYSTEM BY RIA | Apr 5, 1983 | Substantially Equivalent |
| K822935 | THYROID STIMULATING HORMONE | Nov 1, 1982 | Substantially Equivalent |
| K823014 | DIGOXIN KIT | Nov 1, 1982 | Substantially Equivalent |
| K822612 | T3 UPTAKE KITS | Sep 30, 1982 | Substantially Equivalent |
| K820886 | THYROXINE T4 KIT | Apr 16, 1982 | Substantially Equivalent |
| K820358 | FOLLICLE STIMULATING HORMONE KIT | Mar 26, 1982 | Substantially Equivalent |
| K820357 | LUTEINIZING HORMONE KIT | Mar 25, 1982 | Substantially Equivalent |
| K812666 | THYROXINE (T4) 125I | Oct 2, 1981 | Substantially Equivalent |
| K810867 | FOLLICLE STIMULATING HORMONE (FSH) | Apr 14, 1981 | Substantially Equivalent |
| K810852 | FOLLICLE STIMULATING HORMONE ANTISERUM | Apr 8, 1981 | Substantially Equivalent |