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510(k) K851843

OSMOCEL 3 by Hematology Marketing Assoc. — Product Code GIF

K851843 is an FDA 510(k) premarket notification submitted by Hematology Marketing Assoc. for the device "OSMOCEL 3". The FDA issued a decision of Substantially Equivalent on July 30, 1985. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Hematology Marketing Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1985
Date Received
April 26, 1985
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 Hematology Marketing Assoc.

  • K851375 — TRI-COUNT (July 12, 1985)
  • K850095 — LASER-DIL (March 29, 1985)
  • K850094 — LASER-GLOBIN POWDER (March 29, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K850096 — LASER-GLOBIN (March 29, 1985)
  • K844708 — TRI-COUNT CALIBRATOR (March 5, 1985)
  • K843485 — TRI-COUNT LASER (December 12, 1984)
  • K834371 — TRI-COUNT 10 (March 9, 1984)
  • K833130 — TRI-COUNT 7 (October 20, 1983)
  • K831306 — HEMACAL (June 16, 1983)

Other clearances for product code GIF

  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K883990 — KVM ISOTONIC DILUENT (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)
  • K851280 — DASS PACK (July 5, 1985)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K850239 — SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- (April 1, 1985)
  • K850095 — LASER-DIL (March 29, 1985)

FDA data resources