Accusign Tca, Biosign Tca, Staus DS Tca
FDA 510(k) K980249 · Princeton BioMeditech Corp.
510(k) numberK980249
Submission
- Device name
- Accusign Tca, Biosign Tca, Staus DS Tca
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- January 23, 1998
- Decision date
- March 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
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Questions and answers
When was Accusign Tca, Biosign Tca, Staus DS Tca cleared by the FDA?
Accusign Tca, Biosign Tca, Staus DS Tca (K980249) received a 510(k) decision of Substantially Equivalent on March 13, 1998, 49 days after the submission was received.
What is the product code of K980249?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.