510(k) K990786
- Device
- ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/
- Applicant
- PRINCETON BIOMEDITECH CORP.
- 510(k) number
- K990786
- Product code
- LAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-03-26
- Date received
- 1999-03-10
- Regulation
- 862.3610
- Classification name
- High Pressure Liquid Chromatography, Methamphetamine
- 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. Rt. 1 Monmouth Junction NJ US 08852 08852
FDA Registration Numbers#
- 2246703
- 2517506
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LAG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073078 | RAPID TOX CUP | American Bio Medica Corp. | 2008-05-30 |
| K062575 | MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP | Princeton BioMeditech Corp. | 2007-11-26 |
| K983501 | ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/ | Princeton BioMeditech Corp. | 1998-12-18 |
Legacy Summary#
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FDA Review#
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