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510(k) K870491

KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 by Sigma Chemical Co. — Product Code KIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1987
Date Received
February 3, 1987
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

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Other clearances for product code KIP

  • K870482 — (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 (March 30, 1987)
  • K870484 — HANKS' BALANCED SALTS (HBSS) NO. H1387 (March 30, 1987)
  • K870486 — EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 (March 30, 1987)
  • K860784 — DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 (March 12, 1986)
  • K844877 — HEPES BUFFER IM IN NORMAL SALINE (February 25, 1985)
  • K844878 — TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG (February 25, 1985)
  • K842724 — SALINE 0.85% W/O PRESERVATIVE (August 3, 1984)
  • K842725 — SALINE, 0.85%W/PRESERVATIVE (August 3, 1984)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K820927 — HBS POWDER (April 21, 1982)