HEMOCHEK URINE COLLECTION KIT


Device Classification Name

turbidimetric method, protein or albumin (urinary, non-quant.)

510(k) Number K991800
Device Name HEMOCHEK URINE COLLECTION KIT
Applicant
OSBORN GROUP, INC.
14901 west 117th st.
olathe, 
KS 
66062

Applicant Contact gilbert p bourk iii
Correspondent
OSBORN GROUP, INC.
14901 west 117th st.
olathe, 
KS 
66062

Correspodent Contact gilbert p bourk iii
Regulation Number 862.1645
Classification Product Code
JIQ  
Subsequent Product Codes
CGX   FMH  
Date Received 05/26/1999
Decision Date 09/24/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No