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510(k) K871067

MSI HEMATOLOGY CONTROL + by Medical Specialties, Inc. — Product Code JPK

K871067 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "MSI HEMATOLOGY CONTROL +". The FDA issued a decision of Substantially Equivalent on March 25, 1987. 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
March 25, 1987
Date Received
March 18, 1987
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)
  • K931947 — CHECKPOINT (June 18, 1993)
  • 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)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K880608 — MSI-PC (March 21, 1988)
  • K880270 — MSI-DIFF PLUS (March 1, 1988)

Other clearances for product code JPK

  • K160588 — XN CHECK BF (December 22, 2016)
  • K160586 — XN-L CHECK (December 22, 2016)
  • K160590 — XN CHECK (December 22, 2016)
  • K160606 — BC-5D Hematology Control (September 1, 2016)
  • K141957 — XN CHECK BF (December 5, 2014)
  • K141964 — XN CHECK (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