510(k) K991078
- Device
- 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
- Applicant
- PRINCETON BIOMEDITECH CORP.
- 510(k) number
- K991078
- Product code
- DKE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-04-15
- Date received
- 1999-03-26
- Regulation
- 862.3870
- Classification name
- Reagents, Test, Tetrahydrocannabinol
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JEMO KANG
- Address
- 4242 U.S. Rte. 1 P.O. Box 7139 Monmouth Junction NJ US 08852 08852
FDA Registration Numbers#
- 3005360469
- 3008416529
- 1050155
- 1832216
- 2087033
- 3021841051
- 2517506
- 3005345870
- 2029372
- 3043196750
- 3004175381
- 2246703
- 2060833
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 |
| 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 |
| K875182 | MODIFIED LABELING FOR TOXI-LAB THC SCREEN | Marion Laboratories, Inc. | 1988-07-05 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases