510(k) K150602
- Device
- CR3 Keyless Split Sample Cup Morphine - Methamphetamine
- Applicant
- GUANGZHOU WONDFO BIOTECH CO., LTD.
- 510(k) number
- K150602
- Product code
- DNK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-04-07
- Date received
- 2015-03-10
- Regulation
- 862.3640
- Classification name
- Thin Layer Chromatography, Morphine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- BEN CHEN
- Address
- Wondfo Scientech Park South China Univ. Of Technology Guangzhou CN 510641 510641
FDA Registration Numbers#
- 3043127647
- 3023296261
- 3027519599
- 3030413233
- 2060833
- 3006361161
- 3013684380
- 2029372
- 3009585529
- 3021186226
- 3012073813
- 3005360469
- 1832216
- 3010220539
- 3007126977
- 3013679502
- 3024463179
- 3005984081
- 3003917514
- 2030633
- 3008852306
Source Documents#
Other 510(k) Records For Product Code DNK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | Nantong Egens Biotech Co., Ltd. | 2015-07-16 |
| K970579 | ONE STEP MORPHINE CARD TEST | Teco Diagnostics | 1997-07-03 |
| K853140 | MDI QUIK TEST NARCOTICS DRUG SCREEN | Medical Diagnostics, Ca. | 1986-03-03 |
Legacy Summary#
summary
FDA Review#
Decision Summary