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510(k) K860784

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

K860784 is an FDA 510(k) premarket notification submitted by Tissue Culture Innovations for the device "DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2". The FDA issued a decision of Substantially Equivalent on March 12, 1986. The device falls under product code KIP (Formulations, Balanced Salt Solutions), a Class I device regulated under 21 CFR 864.2875. Tissue Culture Innovations has at least 5 other 510(k) clearances on record.

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

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

Other clearances for product code KIP

  • K870486 — EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 (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)
  • K870484 — HANKS' BALANCED SALTS (HBSS) NO. H1387 (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)
  • K842724 — SALINE 0.85% W/O PRESERVATIVE (August 3, 1984)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K842725 — SALINE, 0.85%W/PRESERVATIVE (August 3, 1984)
  • K820923 — DULBECCO'S PBS POWDER (April 21, 1982)

FDA data resources