FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FORETEL, COLOR OVULATION TEST
K Number: K860828
·
Decision Aug 4, 1986
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
9
Review Days
152
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
- FORETEL, COLOR OVULATION TEST
- K Number
- K860828
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nms Pharmaceuticals, Inc.
- Date Received
- March 5, 1986
- Decision Date
- August 4, 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 Nms Pharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861202 | TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS | Jan 9, 1987 | Substantially Equivalent |
| K854236 | HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS | Oct 10, 1986 | Substantially Equivalent for Some Indications |
| K853925 | QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA | Dec 2, 1985 | Substantially Equivalent |
| K851445 | COLOR OVULATION TEST | Jul 29, 1985 | Substantially Equivalent |
| K850431 | EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL | Jun 17, 1985 | Substantially Equivalent |
| K850786 | TOTAL HIGE ENZYME IMMUNOASSAY | Apr 12, 1985 | Substantially Equivalent |
| K850787 | SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY | Mar 26, 1985 | Substantially Equivalent |
| K842499 | NMS 1043 ENZYME IMMUNOASSAY KIT | Sep 14, 1984 | Substantially Equivalent |