FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AT HOME OVULATION TEST, MODEL 9032
K Number: K021409
·
Decision May 24, 2002
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
15
Review Days
21
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
- AT HOME OVULATION TEST, MODEL 9032
- K Number
- K021409
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech, Inc.
- Date Received
- May 3, 2002
- Decision Date
- May 24, 2002
- 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
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
SURE CHECK OVULATION PREDICTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Phamatech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | Oct 18, 2018 | Substantially Equivalent |
| K131069 | QUICKSCREEN AMPHETINE 500 TEST | May 14, 2014 | Substantially Equivalent |
| K103295 | QUICKSCREEN COCAINE 150 SCREENING TEST | Feb 1, 2012 | Substantially Equivalent |
| K070009 | AT HOME DRUG TEST MODELS, 9308T AND 9308X | Dec 7, 2007 | Substantially Equivalent |
| K070098 | QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC | Dec 7, 2007 | Substantially Equivalent |
| K043599 | MOMENTS MENOPAUSE CHECK, MODEL 9113 | Feb 25, 2005 | Substantially Equivalent |
| K043051 | QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121 | Feb 7, 2005 | Substantially Equivalent |
| K043167 | PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X | Dec 29, 2004 | Substantially Equivalent |
| K040575 | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 | May 20, 2004 | Substantially Equivalent |
| K013408 | AT HOME DRUG TEST, MODEL 9079 | Dec 6, 2001 | Substantially Equivalent |