510(k) K972577
- Device
- QUICK SCREEN ONE STEP AMPHETAMINE TEST
- Applicant
- PHAMATECH
- 510(k) number
- K972577
- Product code
- DIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-20
- Date received
- 1997-07-10
- Regulation
- 862.3100
- Classification name
- Thin Layer Chromatography, Amphetamine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARL MONGIOVI
- Address
- 9265 Activity Rd., #112-113 San Diego CA US 92126 92126
FDA Registration Numbers#
- 2031229
Source Documents#
Other 510(k) Records For Product Code DIT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910525 | MICROLINE SCREEN FOR METHAMPHETAMINE | Drug Screening Systems, Inc. | 1991-04-05 |
| K901276 | HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL | Diagnostic Products Corp. | 1990-04-26 |
| K790805 | DRUG ABUSE DIPSTICKS | Technical Resources, Inc. | 1979-06-06 |
Legacy Summary#
summary
FDA Review#
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