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510(k) K781584

GRAM STAIN KIT by Bioscientific — Product Code HYI

K781584 is an FDA 510(k) premarket notification submitted by Bioscientific for the device "GRAM STAIN KIT". The FDA issued a decision of Substantially Equivalent on October 10, 1978. The device falls under product code HYI (Iodine, Grams), a Class I device regulated under 21 CFR 864.1850. Bioscientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
September 18, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iodine, Grams
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

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)
  • K781734 — SODIUM CHLORIDE, 0.85% (October 24, 1978)
  • K781585 — HEMATOXYLIN STAIN HARRIS (October 10, 1978)

Other clearances for product code HYI

  • K871286 — GRAM IODINE (April 8, 1987)
  • K842733 — GRAM IODINE (August 10, 1984)
  • K821977 — GRAMSTAIN SET (July 22, 1982)
  • K811722 — PARA-PAK (July 15, 1981)
  • K791711 — IMPROVED GRAM STAIN REAGENTS (October 17, 1979)

FDA data resources