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510(k) K830188

OSMOCEL + by Hematology Marketing Assoc. — Product Code GIF

K830188 is an FDA 510(k) premarket notification submitted by Hematology Marketing Assoc. for the device "OSMOCEL +". The FDA issued a decision of Substantially Equivalent on March 1, 1983. 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
March 1, 1983
Date Received
January 19, 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 Hematology Marketing Assoc.

  • K851843 — OSMOCEL 3 (July 30, 1985)
  • K851375 — TRI-COUNT (July 12, 1985)
  • K850096 — LASER-GLOBIN (March 29, 1985)
  • K850095 — LASER-DIL (March 29, 1985)
  • K850097 — LASER-LYSE (March 29, 1985)
  • K850094 — LASER-GLOBIN POWDER (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)

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