ORTHO HEMATOLOGY CONTROL ABNORMAL LOW— 510(k) K803084

Clearance details

Applicant

Ortho Instruments

Product code

Code JPK

Device class

Class 2

Regulation

21 CFR 864.8625

Advisory panel

Hematology

Date received

1980-12-05

Decision date

1980-12-31

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K160586 — XN-L CHECK2016-12-22
• K160588 — XN CHECK BF2016-12-22
• K160590 — XN CHECK2016-12-22
• K160606 — BC-5D Hematology Control2016-09-01
• K141957 — XN CHECK BF2014-12-05

• K803073 — ORTHO HEMATOLOGY CONTROL1980-12-31
• K803083 — ORTHO HEMOTOLOGY CONTROL-NORMAL1980-12-31
• K802094 — ORTHO SPECTRUM1980-10-10
• K801545 — ORTHO AUTOMATED CELL COUNTER1980-09-09
• K781146 — HEMAC LASER HEMATOLOGY SYSTEM1978-09-14