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510(k) K860784

DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 by Tissue Culture Innovations — Product Code KIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1986
Date Received
March 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formulations, Balanced Salt Solutions
Device Class
Class I
Regulation Number
864.2875
Review Panel
PA
Submission Type

Other clearances by Tissue Culture Innovations

  • K860786 — RPMI 1640 HEPES (March 12, 1986)
  • K860787 — DULBECCO'S MEM (March 12, 1986)
  • K860783 — MICRO CARRIER (March 12, 1986)
  • K860788 — HAM'S F-12 W/GLUTAMINE & NAHCO3 (March 12, 1986)
  • K860785 — HAM'S F-12 W/NAHCO3 (March 12, 1986)

Other clearances for product code KIP

  • K870484 — HANKS' BALANCED SALTS (HBSS) NO. H1387 (March 30, 1987)
  • K870482 — (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 (March 30, 1987)
  • K870491 — KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 (March 30, 1987)
  • K870486 — EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 (March 30, 1987)
  • K844878 — TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG (February 25, 1985)
  • K844877 — HEPES BUFFER IM IN NORMAL SALINE (February 25, 1985)
  • K842725 — SALINE, 0.85%W/PRESERVATIVE (August 3, 1984)
  • K842724 — SALINE 0.85% W/O PRESERVATIVE (August 3, 1984)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K820927 — HBS POWDER (April 21, 1982)