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510(k) K861869

GENTAMICIN-50MG/ML by Hazleton Research Products, Inc. — Product Code KIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1986
Date Received
May 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
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)

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  • K890482 — ABC, ABC-1X, ABC(TM) (February 10, 1989)
  • K884654 — ALPHACALF SERUM (November 30, 1988)
  • K884572 — RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (November 22, 1988)
  • K884574 — DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (November 22, 1988)
  • K884573 — HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (November 22, 1988)
  • K883065 — ALLOPREP SYSTEM (October 13, 1988)
  • K884031 — FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (October 6, 1988)