FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DBEST ONE-STEP HCG SERUM/URINE TEST
K Number: K973957
·
Decision Dec 17, 1997
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
17
Review Days
62
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Basic Information
- Device Name
- DBEST ONE-STEP HCG SERUM/URINE TEST
- K Number
- K973957
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ameritek, Inc.
- Date Received
- October 16, 1997
- Decision Date
- December 17, 1997
- Product Code
- JHI
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K974508 | DBEST ONE-STEP OVULATION TEST | Feb 2, 1998 | Substantially Equivalent |