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510(k) K940430

SEDRATROL by Medical Specialties Intl., Inc. — Product Code GJR

K940430 is an FDA 510(k) premarket notification submitted by Medical Specialties Intl., Inc. for the device "SEDRATROL". The FDA issued a decision of Substantially Equivalent on February 6, 1995. The device falls under product code GJR (Control, Red-Cell), 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
February 6, 1995
Date Received
January 31, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Red-Cell
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)
  • K895373 — HEMATOLOGY CONTROL (October 6, 1989)

Other clearances for product code GJR

  • K080016 — NRBC-CHEX FOR ADVIA (February 5, 2008)
  • K060083 — NRBC-CHEX FOR LH (February 9, 2006)
  • K000076 — CELL-CHEX (March 3, 2000)
  • K900484 — RET-CHECK (March 9, 1990)

FDA data resources