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510(k) K791658

WRIGHT STAIN PACK by Bioscientific

K791658 is an FDA 510(k) premarket notification submitted by Bioscientific for the device "WRIGHT STAIN PACK". The FDA issued a decision of Substantially Equivalent on October 17, 1979. Bioscientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1979
Date Received
August 21, 1979
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)
  • K791007 — STAT DIFF STAIN (August 3, 1979)
  • K790415 — HCP-7 (April 4, 1979)
  • K781734 — SODIUM CHLORIDE, 0.85% (October 24, 1978)
  • K781584 — GRAM STAIN KIT (October 10, 1978)
  • K781588 — PAPANICOLAOU STIAN OG-6 (October 10, 1978)

FDA data resources