Home / 510(k) Clearances / K895373

510(k) K895373

HEMATOLOGY CONTROL by Medical Specialties Intl., Inc. — Product Code JCN

K895373 is an FDA 510(k) premarket notification submitted by Medical Specialties Intl., Inc. for the device "HEMATOLOGY CONTROL". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code JCN (Control, Cell Counter, Normal And Abnormal), a Class II device regulated under 21 CFR 864.8625. Medical Specialties Intl., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
August 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Cell Counter, Normal And Abnormal
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Medical Specialties Intl., Inc.

  • K972655 — CONTROL SYRINGE (November 4, 1997)
  • K972654 — MANIFOLD (October 8, 1997)
  • K952385 — HEMA-TROL Q-CHECK (September 25, 1995)
  • K940430 — SEDRATROL (February 6, 1995)

Other clearances for product code JCN

  • K993825 — PARA TECH PLUS RETICS (November 30, 1999)
  • K942209 — LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH (June 16, 1994)
  • K934497 — CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE (December 6, 1993)
  • K911582 — STAK-CHEX (May 28, 1991)
  • K902389 — TRI-COUNT 16 (August 22, 1990)
  • K902391 — CELL-DYN 3000 CONTROL (August 22, 1990)
  • K901875 — PARA 12 PLUS (May 30, 1990)
  • K896154 — PARA TECH FOR TECHNICON H-1 (November 9, 1989)
  • K891907 — QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED (April 11, 1989)
  • K874386 — CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE (December 30, 1987)

FDA data resources