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510(k) K811251

CITRATE BUFFER by Bioscientific — Product Code JCC

K811251 is an FDA 510(k) premarket notification submitted by Bioscientific for the device "CITRATE BUFFER". The FDA issued a decision of Substantially Equivalent on May 21, 1981. The device falls under product code JCC (Ph Buffer), a Class I device regulated under 21 CFR 864.4010. Bioscientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1981
Date Received
May 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Buffer
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Bioscientific

  • K812447 — AMYLASE REAGENT KIT (September 9, 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)
  • K781584 — GRAM STAIN KIT (October 10, 1978)
  • K781585 — HEMATOXYLIN STAIN HARRIS (October 10, 1978)

Other clearances for product code JCC

  • K842918 — SCOTTS TAP WATER SUBSTITUTE (September 11, 1984)
  • K842914 — WRIGHT STAIN BUFFER (September 7, 1984)
  • K841423 — SCOTTS TAP WATER SUBSTITUTE 7 (May 22, 1984)
  • K811791 — PHOSPHATE BUFFERED SALINE (1X) (August 25, 1981)
  • K792574 — MOPSO BUFFER (January 21, 1980)
  • K770508 — SMAC SYSTEM (May 9, 1977)

FDA data resources