510(k) K875182
- Device
- MODIFIED LABELING FOR TOXI-LAB THC SCREEN
- Applicant
- MARION LABORATORIES, INC.
- 510(k) number
- K875182
- Product code
- DKE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-07-05
- Date received
- 1987-12-17
- Regulation
- 862.3870
- Classification name
- Reagents, Test, Tetrahydrocannabinol
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GUINTY, JR
- Address
- P.O. Box 9627 Kansas City MI US 64134 64134
FDA Registration Numbers#
- 2060833
- 3005345870
- 1832216
- 2029372
- 2246703
- 3008416529
- 3005360469
- 3004175381
- 3021841051
- 2087033
- 2517506
- 1050155
- 3043196750
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DKE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003687 | VERDICT II THC/COC/OPI/AMP, VERDICTII THC/COC/OPI,VERDICT II THC/COC/AMP,VERDICT II THC/COC/PCP,VERDICT II THC/COC | Medtox Diagnostics, Inc. | 2000-12-22 |
| K994405 | INSTANT-VIEW MARIJUANA URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2000-06-02 |
| K992068 | STATUS STIK, ACCUSIGN STIK | Princeton BioMeditech Corp. | 1999-07-06 |
| K991751 | STATUS CUP ACCUSIGN CUP | Princeton BioMeditech Corp. | 1999-06-18 |
| K991078 | ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8 | Princeton BioMeditech Corp. | 1999-04-15 |
| K983147 | ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P | Princeton BioMeditech Corp. | 1998-09-28 |
| K982211 | PROFILE-II MODEL 600582 | Medtox Diagnostics, Inc. | 1998-07-29 |
| K901694 | SPEC(TM) EXTRACTION CARTRIDGE | Toxi-Lab, Inc. | 1990-06-01 |
| K841831 | CANNU-SKREEN-PRELIMINARY | Biochemical Diagnostic, Inc. | 1984-07-06 |
| K831456 | TOXI-LAB CANNABINOID THC SCREEN | Marion Laboratories, Inc. | 1983-06-30 |
| K792282 | DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG | California Medical Developments, Inc. | 1980-02-29 |
Legacy Summary#
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FDA Review#
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