NEW MULTIPLES REAGENT STRIPS


Device Classification Name

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

510(k) Number K992257
Device Name NEW MULTIPLES REAGENT STRIPS
Applicant
BAYER CORP.
1884 miles ave.
elkhart, 
IN 
46514

Applicant Contact syed ataullah
Correspondent
BAYER CORP.
1884 miles ave.
elkhart, 
IN 
46514

Correspodent Contact syed ataullah
Regulation Number 862.1645
Classification Product Code
JIR  
Subsequent Product Codes
CDM   CEN   JFY   JIL   JIN  
JIO   JJB   JMT   JRE   LJX  
Date Received 07/06/1999
Decision Date 11/24/1999
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