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510(k) K832116

ATAC 4700 HEMATOLOGY CELL COUNTER by Turpen Laboratory Systems, Inc. — Product Code GIF

K832116 is an FDA 510(k) premarket notification submitted by Turpen Laboratory Systems, Inc. for the device "ATAC 4700 HEMATOLOGY CELL COUNTER". The FDA issued a decision of Substantially Equivalent on October 20, 1983. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Turpen Laboratory Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1983
Date Received
June 30, 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 Turpen Laboratory Systems, Inc.

  • K870836 — ATAC 1500 CHEMISTRY ANALYZER (April 1, 1987)
  • K863332 — ATAC 4300 HEMATOLOGY CELL COUNTER (September 29, 1986)
  • K851321 — ATAC 2000 CHEMISTRY ANALYZER (April 25, 1985)
  • K843059 — ATAC 2000 (October 11, 1984)
  • K832115 — ATAC 3000 (January 10, 1984)

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