Home / 510(k) Clearances / K931947

510(k) K931947

CHECKPOINT by Medical Specialties, Inc. — Product Code JPK

K931947 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "CHECKPOINT". The FDA issued a decision of Substantially Equivalent on June 18, 1993. The device falls under product code JPK (Mixture, Hematology Quality Control), a Class II device regulated under 21 CFR 864.8625. Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1993
Date Received
April 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixture, Hematology Quality Control
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Medical Specialties, Inc.

  • K946201 — STAND, INFUSION (April 18, 1995)
  • K926095 — REFRACTROL-SP (January 26, 1993)
  • K924926 — MSI-HCT (January 7, 1993)
  • K896566 — MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE (February 9, 1990)
  • K883851 — MSI-CAL 8 (November 22, 1988)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K880608 — MSI-PC (March 21, 1988)
  • K880270 — MSI-DIFF PLUS (March 1, 1988)
  • K872140 — (MSI) PATH-SAVER (June 15, 1987)

Other clearances for product code JPK

  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141964 — XN CHECK (December 5, 2014)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K130962 — R&D 5D RETIC HEMATOLOGY CONTROL (July 24, 2013)
  • K120742 — XN CHECK (October 19, 2012)
  • K120744 — XN CHECK BF (October 19, 2012)
  • K101578 — R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL (April 28, 2011)

FDA data resources