MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)


Device Classification Name

manual antimicrobial susceptibility test systems

510(k) Number K992143
Device Name MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)
Applicant
PASCO LABORATORIES, INC.
12750 west 42nd ave.
wheat ridge, 
CO 
80033

Applicant Contact linda k dillon
Correspondent
PASCO LABORATORIES, INC.
12750 west 42nd ave.
wheat ridge, 
CO 
80033

Correspodent Contact linda k dillon
Regulation Number 866.1640
Classification Product Code
JWY  
Date Received 06/24/1999
Decision Date 09/16/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No