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510(k) K822325

BLOOD CELL DILUENT 78N 1913 by Interscience, Inc. — Product Code GIF

K822325 is an FDA 510(k) premarket notification submitted by Interscience, Inc. for the device "BLOOD CELL DILUENT 78N 1913". The FDA issued a decision of Substantially Equivalent on October 18, 1982. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Interscience, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1982
Date Received
August 3, 1982
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 Interscience, Inc.

  • K822327 — CALIBRATOR FOR HEMOGLOBIN & HEMOCRIT (November 16, 1982)
  • K822324 — RED CELL LYSING REAGENT 78N 1915-1 (November 8, 1982)
  • K822326 — BLENDED DETERGENT-78N 1912-1 (October 18, 1982)

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