INCSTAR RUBELLA IGG FAST ELISA ASSAY


Device Classification Name

enzyme linked immunoabsorbent assay, rubella

510(k) Number K960358
Device Name INCSTAR RUBELLA IGG FAST ELISA ASSAY
Applicant
INCSTAR CORP.
1990 industrial blvd.
p.o. box 285
stillwater, 
MN 
55082

Applicant Contact mary frick
Correspondent
INCSTAR CORP.
1990 industrial blvd.
p.o. box 285
stillwater, 
MN 
55082

Correspodent Contact mary frick
Regulation Number 866.3510
Classification Product Code
LFX  
Date Received 01/25/1996
Decision Date 10/24/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized