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510(k) K812309

CRYOSAN NORMAL SALINE by Cryosan, Inc. — Product Code GIF

K812309 is an FDA 510(k) premarket notification submitted by Cryosan, Inc. for the device "CRYOSAN NORMAL SALINE". The FDA issued a decision of Substantially Equivalent on September 16, 1981. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Cryosan, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1981
Date Received
August 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diluent, Blood Cell
Device Class
Class I
Regulation Number
864.8200
Review Panel
HE
Submission Type

Other clearances by Cryosan, Inc.

  • K831953 — INFUSION PUMP (July 19, 1983)
  • K830831 — AUTOMATED BLOOD CELL SEPARATOR (June 16, 1983)
  • K822521 — AUTOMATED BLOOD CELL SEPARATOR (September 30, 1982)
  • K813489 — ROCKING/CIRCULATING CYTO-THERM II 3570 (March 4, 1982)
  • K812311 — CIRCULATING CYTO-THERMS (September 16, 1981)

Other clearances for product code GIF

  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K882490 — HYCEL QUICK-LYSING HEMOGLOBIN REAGENT (July 25, 1988)
  • K882267 — SYSMEX QUICKLYSER-II (QLS-200A) (July 12, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851280 — DASS PACK (July 5, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)

FDA data resources