URS-1B (BLOOD TEST)


Device Classification Name

blood, occult, colorimetric, in urine

510(k) Number K023297
Device Name URS-1B (BLOOD TEST)
Original Applicant
TECO DIAGNOSTICS
1268 . lakeview ave.
anaheim, 
CA 
92807

Original Contact lisa to
Regulation Number 864.6550
Classification Product Code
JIO  
Date Received 10/02/2002
Decision Date 03/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No