510(k) K972618
- Device
- QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)
- Applicant
- PHAMATECH
- 510(k) number
- K972618
- Product code
- DMN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-08
- Date received
- 1997-07-11
- Regulation
- 862.3250
- Classification name
- Thin Layer Chromatography, Cocaine
- 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
- 9520 Padgett St. #108-110 San Diego CA US 92126 92126
FDA Registration Numbers#
- 2031229
Source Documents#
Other 510(k) Records For Product Code DMN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874389 | CRACK-IT CHAP SCREEN | Sakers, Inc. | 1989-02-07 |
Legacy Summary#
summary
FDA Review#
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