Submission Details
| 510(k) Number | K983501 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 06, 1998 |
| Decision Date | December 18, 1998 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
Cleared
Traditional
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/
(FDA 510(k) Clearance)
Dec 1998
Decision
73d
Days
Class 2
Risk
K983501 is an FDA 510(k) clearance for the ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/, a High Pressure Liquid Chromatography, Methamphetamine (Class II — Special Controls, product code LAG), submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on December 18, 1998, 73 days after receiving the submission on October 6, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.
Device Classification
| Product Code | LAG — High Pressure Liquid Chromatography, Methamphetamine |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3610 |
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