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510(k) K861823

GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) by Flow Laboratories, Inc. — Product Code JSK

K861823 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)". The FDA issued a decision of Substantially Equivalent on May 20, 1986. The device falls under product code JSK (Supplement, Culture Media), a Class I device regulated under 21 CFR 866.2450. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1986
Date Received
May 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplement, Culture Media
Device Class
Class I
Regulation Number
866.2450
Review Panel
MI
Submission Type

Other clearances by Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K862066 — TITERTEK MICROPLATE WASHER S-12 (June 5, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K860762 — GAMMA-FREE HORSE SERUM (March 10, 1986)
  • K860752 — GOAT SERUM (29-391-54) (March 10, 1986)
  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844567 — TITERTEK TWINREADER 78-630-00 (March 21, 1985)

Other clearances for product code JSK

  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (May 13, 1988)
  • K881566 — HEMOGLOBIN POWDER (April 18, 1988)
  • K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (June 10, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K855172 — KWI (TM) G-CO/TWO (February 20, 1986)
  • K853546 — ABBOTT CATION SUPPLEMENT SOLUTION (September 6, 1985)
  • K850302 — SUPLEX & SUPLEX DILUENT (March 22, 1985)
  • K850308 — C.L.A.T. (March 20, 1985)

FDA data resources