FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LH RIA
K Number: K842445
·
Decision Sep 4, 1984
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
31
Review Days
75
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
- LH RIA
- K Number
- K842445
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Syncor Intl. Corp.
- Date Received
- June 21, 1984
- Decision Date
- September 4, 1984
- 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 Syncor Intl. Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K945825 | SECURE SAFETY INSERT | Apr 10, 1995 | Substantially Equivalent |
| K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C | Sep 19, 1985 | Substantially Equivalent |
| K850433 | CESIUM 137 ENDOMETRIAL SOURCE | Aug 21, 1985 | Substantially Equivalent |
| K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 | Aug 21, 1985 | Substantially Equivalent |
| K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY | Aug 13, 1985 | Substantially Equivalent |
| K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT | Jun 21, 1985 | Substantially Equivalent |
| K844735 | PTH-RIA | Apr 29, 1985 | Substantially Equivalent |
| K850163 | IRIDIUM 192 WIRES | Mar 26, 1985 | Substantially Equivalent |
| K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS | Mar 26, 1985 | Substantially Equivalent |
| K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD | Mar 26, 1985 | Substantially Equivalent |