URINE MONOVETTE BORIC ACID


Device Classification Name

culture media, non-propagating transport

510(k) Number K024237
Device Name URINE MONOVETTE BORIC ACID
Original Applicant
SARSTEDT, INC.
1025 st. james church rd.
newton, 
NC 
28658

Original Contact peter rumswinkel
Regulation Number 866.2390
Classification Product Code
JSM  
Date Received 12/23/2002
Decision Date 04/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No