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510(k) K800180

VARIOUS REAGENTS FOR BLOOD CELL ANALYZER by Laboratory Products, Inc. — Product Code GIF

K800180 is an FDA 510(k) premarket notification submitted by Laboratory Products, Inc. for the device "VARIOUS REAGENTS FOR BLOOD CELL ANALYZER". The FDA issued a decision of Substantially Equivalent on March 19, 1980. The device falls under product code GIF (Diluent, Blood Cell), a Class I device regulated under 21 CFR 864.8200. Laboratory Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1980
Date Received
January 29, 1980
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 Laboratory Products, Inc.

  • K832588 — CIN AGAR (September 12, 1983)
  • K803051 — FLAME PHOTOMETRY REAGENTS (January 9, 1981)
  • K803013 — CHLORIDE/TCO2 ANALYZER REAGENTS (January 2, 1981)
  • K803050 — SPRAY, SYNTHETIC SMEAR (December 30, 1980)
  • K792482 — CHEMISTRY ANALYZER REAGENTS (January 11, 1980)
  • K792481 — CULTURE PLATES & TUBED MEDIA (December 31, 1979)
  • K792483 — STAINS, COUNTERSTAINS & GEN. PURPOSE (December 18, 1979)

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