DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM


definition

Device Classification Name

enzyme linked immunoabsorbent assay, herpes simplex virus, non-specific

510(k) Number K002262
Device Name DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
Original Applicant
DIAMEDIX CORP.
2140 north miami ave.
miami, 
FL 
33127

Original Contact lynne stirling
Regulation Number 866.3305
Classification Product Code
LGC  
Date Received 07/25/2000
Decision Date 11/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls