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510(k) K781734

SODIUM CHLORIDE, 0.85% by Bioscientific

K781734 is an FDA 510(k) premarket notification submitted by Bioscientific for the device "SODIUM CHLORIDE, 0.85%". The FDA issued a decision of Substantially Equivalent on October 24, 1978. Bioscientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1978
Date Received
October 12, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Bioscientific

  • K812447 — AMYLASE REAGENT KIT (September 9, 1981)
  • K811251 — CITRATE BUFFER (May 21, 1981)
  • K801267 — RED BLOOD CELL COUNT & HEMATOCRIT CNTL (July 14, 1980)
  • K801268 — HEMOGLOBIN CONTROL LEVELS (July 14, 1980)
  • K801265 — WHITE BLOOD CELL COUNT CONTROL LEVELS (July 14, 1980)
  • K791658 — WRIGHT STAIN PACK (October 17, 1979)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K790415 — HCP-7 (April 4, 1979)
  • K781583 — PAPANICOLAOU STAIN :EA-50: (October 10, 1978)
  • K781584 — GRAM STAIN KIT (October 10, 1978)

FDA data resources