ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
FDA 510(k) clearance K981801 · decided 1998-08-25
Clearance details
- K-number
- K981801
- Device name
- ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
- Applicant
- Princeton BioMeditech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-05-21
- Decision date
- 1998-08-25
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- LFH
- Device class
- 2
- Regulation number
- 862.3910
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.