ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100


codes

Device Classification Name

enzyme immunoassay, inhibin-a

510(k) Number K002128
Device Name ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
Original Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 medical center blvd.
webster, 
TX 
77598

Original Contact michael (rusty) nicar
Regulation Number 862.1260
Classification Product Code
NDR  
Date Received 07/14/2000
Decision Date 12/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls