URINE DRUG SCREENING CONTROL


Device Classification Name

drug mixture control materials

510(k) Number K992395
Device Name URINE DRUG SCREENING CONTROL
Applicant
SERACARE TECHNOLOGY
2170 woodward st.
austin, 
TX 
78744 -1832

Applicant Contact rusty sewell
Correspondent
SERACARE TECHNOLOGY
2170 woodward st.
austin, 
TX 
78744 -1832

Correspodent Contact rusty sewell
Regulation Number 862.3280
Classification Product Code
DIF  
Date Received 07/19/1999
Decision Date 08/26/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No