Home / 510(k) Clearances / K880608

510(k) K880608

MSI-PC by Medical Specialties, Inc. — Product Code GJP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1988
Date Received
February 12, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Platelet
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)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K880270 — MSI-DIFF PLUS (March 1, 1988)
  • K872140 — (MSI) PATH-SAVER (June 15, 1987)

Other clearances for product code GJP

  • K823930 — HEMATOLOGY QUALITY CONTROL MIXTURE (February 1, 1983)
  • K771588 — PLATELET CONTROLS NORMAL & ABNORMAL (August 25, 1977)
  • K770655 — LATELET DETERMIBATION KIT, UL 800 (June 24, 1977)