FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LEE-BEAD BETA LH (EIA)
K Number: K854838
·
Decision Jan 7, 1986
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
49
Review Days
35
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
- LEE-BEAD BETA LH (EIA)
- K Number
- K854838
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Leeco Diagnostics, Inc.
- Date Received
- December 3, 1985
- Decision Date
- January 7, 1986
- 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 Leeco Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895765 | LEECO PREVIEW(R) EBV (EIA) | Oct 31, 1989 | Substantially Equivalent |
| K894122 | LEECO VIS-DISK STREP-A (EIA) | Aug 15, 1989 | Substantially Equivalent |
| K891095 | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M | Jun 16, 1989 | Substantially Equivalent |
| K891096 | VIS-DISK HCG (EIA) JPL-041M | Jun 16, 1989 | Substantially Equivalent |
| K883269 | PRL-QUANT | Sep 13, 1988 | Substantially Equivalent |
| K880577 | CONCEP-7-BHCG | Mar 15, 1988 | Substantially Equivalent |
| K880069 | LEECO PREGNASTICK (EIA) CATALOG #003 | Feb 11, 1988 | Substantially Equivalent |
| K870259 | VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 | Mar 10, 1987 | Substantially Equivalent |
| K864170 | LEECO VIS-CUBE STREP A (EIA) | Feb 3, 1987 | Substantially Equivalent |
| K863999 | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 | Jan 9, 1987 | Substantially Equivalent |