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510(k) K844877

HEPES BUFFER IM IN NORMAL SALINE by Hazleton Research Products, Inc. — Product Code KIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
December 17, 1984
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 Hazleton Research Products, Inc.

  • K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (June 10, 1986)
  • K861996 — DULBECCO'S MEM WITH 4.5 G/L GLUCOSE MEDIUM (June 9, 1986)
  • K861872 — ISCOVE'S (MODIFIED) DULBECCO'S MEDIUM (May 29, 1986)
  • K861887 — MEM GLASGOW POWDERED MEDIUM (May 29, 1986)
  • K861875 — RPMI-1640 MEDIUM WITH 25MM HEPES BUFFER (May 29, 1986)
  • K861868 — WILLIAMS MEDIUM E (May 29, 1986)
  • K861873 — MEM GLASGOW MEDIUM (May 29, 1986)
  • K861885 — WILLIAMS MEDIUM E POWDER (May 29, 1986)
  • K861870 — DULBECCO'S MODIFIED EAGLE MED. W/25MM HEPES BUFFER (May 29, 1986)
  • K861886 — DMEM & HAM'S F-12 (1:1) POWDERED MEDIUM (May 29, 1986)

Other clearances for product code KIP

  • 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)
  • K870484 — HANKS' BALANCED SALTS (HBSS) NO. H1387 (March 30, 1987)
  • K860784 — DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2 (March 12, 1986)
  • K844878 — TRYPSIN 10X - 1:250 IN HBSS W/O CA & MG (February 25, 1985)
  • K842723 — SALINE, 1.3% W/O PRESERVATIVE (August 3, 1984)
  • K842725 — SALINE, 0.85%W/PRESERVATIVE (August 3, 1984)
  • K842724 — SALINE 0.85% W/O PRESERVATIVE (August 3, 1984)
  • K820927 — HBS POWDER (April 21, 1982)