FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/
K Number: K983501
·
Decision Dec 18, 1998
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
72
Review Days
73
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/
- K Number
- K983501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Princeton BioMeditech Corp.
- Date Received
- October 6, 1998
- Decision Date
- December 18, 1998
- Product Code
- LAG
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LAG | High Pressure Liquid Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LAG), ordered by most recent decision date.
RAPID TOX CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Princeton BioMeditech Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K251538 | Status COVID-19/Flu A&B | Nov 14, 2025 | Substantially Equivalent |
| K182157 | BioSign Flu A+B | Sep 18, 2018 | Substantially Equivalent |
| K130650 | STATUS DS OXY | Feb 26, 2014 | Substantially Equivalent |
| K133474 | BIOSIGN FLU A + B, STATUS FLU A & B | Dec 10, 2013 | Substantially Equivalent |
| K132465 | BIOSIGN FLU A + B, STATUS FLU A & B | Sep 9, 2013 | Substantially Equivalent |
| K083746 | BIOSIGN FLU A+B | Nov 10, 2010 | Substantially Equivalent |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Jul 1, 2010 | Substantially Equivalent |
| K100341 | SPERMCHECK FERTILITY | May 4, 2010 | Substantially Equivalent |
| K082661 | BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A | Oct 6, 2008 | Substantially Equivalent |
| K073039 | SPERMCHECK VASECTOMY | Jan 24, 2008 | Substantially Equivalent |