FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DBEST ONE-STEP OVULATION TEST
K Number: K974508
·
Decision Feb 2, 1998
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
142
Applicant Total
17
Review Days
63
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Basic Information
- Device Name
- DBEST ONE-STEP OVULATION TEST
- K Number
- K974508
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1485
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ameritek, Inc.
- Date Received
- December 1, 1997
- Decision Date
- February 2, 1998
- 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 |
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Other Clearances by Ameritek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K001215 | DBEST HCG 2 IU/ML TEST KIT | Jun 22, 2000 | Substantially Equivalent |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Sep 1, 1999 | Substantially Equivalent |
| K990681 | DBSET MULTIDRUG SCREEN TEST KIT | Jul 15, 1999 | Substantially Equivalent |
| K984269 | DBEST OCCULT BLOOD TEST KIT | May 11, 1999 | Substantially Equivalent |
| K983191 | DBEST COCAINE TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983190 | DBEST OPIATES TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K983189 | DBEST METHAMPHETAMINES TEST KIT | Nov 18, 1998 | Substantially Equivalent |
| K981504 | DBEST AMPHETAMINES TEST KIT | Aug 6, 1998 | Substantially Equivalent |
| K973957 | DBEST ONE-STEP HCG SERUM/URINE TEST | Dec 17, 1997 | Substantially Equivalent |