510(k) K062575
- Device
- MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
- Applicant
- PRINCETON BIOMEDITECH CORP.
- 510(k) number
- K062575
- Product code
- LAG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-11-26
- Date received
- 2006-08-31
- Regulation
- 862.3610
- Classification name
- High Pressure Liquid Chromatography, Methamphetamine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KYUNG-AH KIM
- Address
- 4242 U.S. Rt. 1 Monmouth Junction NJ US 08852 08852
FDA Registration Numbers#
- 2246703
- 2517506
Source Documents#
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 |
| K990786 | ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/ | Princeton BioMeditech Corp. | 1999-03-26 |
| 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#
summary
FDA Review#
Decision Summary