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510(k) K833443

ISOTONIC BLOOD CELL DILUENT J & S by Jasins & Sayles Associates, Inc. — Product Code GIF

K833443 is an FDA 510(k) premarket notification submitted by Jasins & Sayles Associates, Inc. for the device "ISOTONIC BLOOD CELL DILUENT J & S". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Jasins & Sayles Associates, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
October 5, 1983
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 Jasins & Sayles Associates, Inc.

  • K833444 — LYSING & HEMOGLOBIN S-REAGENT J & S (November 3, 1983)

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