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510(k) K781103

SPECTRASCAN by Medishield, Inc. — Product Code DAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1978
Date Received
July 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

Other clearances by Medishield, Inc.

  • K780645 — HMD-2000 BATTERY-POWERED MINI-DRILL, THE (May 3, 1978)
  • K780646 — AIR-PWOERED COLDRILL (April 28, 1978)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K770161 — MICROFENESTRATED HIP REPLACEMENT COMPON. (January 26, 1977)
  • K761021 — ANKLE INSTRUMENTS (FREEMAN-SWANSON) (November 23, 1976)
  • K761020 — ANKLE (FREEMAN-SWANSON) (November 23, 1976)
  • K760668 — SELECTATEC SYSTEM (September 27, 1976)

Other clearances for product code DAT

  • K924892 — FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM (April 21, 1994)