MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992

codes

Device Classification Name

tubes, vials, systems, serum separators, blood collection

510(k) Number K002456
Device Name MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
Original Applicant
BECTON DICKINSON VACUTAINER SYSTEMS
one becton dr.
franklin lakes, 
NJ 
07417 -1885

Original Contact james haynes
Regulation Number 862.1675
Classification Product Code
JKA  
Date Received 08/10/2000
Decision Date 11/02/2000
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