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510(k) K781388

F.A. MOUNTING MEDIUM by Flow Laboratories, Inc. — Product Code KEQ

K781388 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "F.A. MOUNTING MEDIUM". The FDA issued a decision of Substantially Equivalent on August 21, 1978. The device falls under product code KEQ (Media, Mounting, Water Soluble), a Class I device regulated under 21 CFR 864.4010. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1978
Date Received
August 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Mounting, Water Soluble
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K862066 — TITERTEK MICROPLATE WASHER S-12 (June 5, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K860752 — GOAT SERUM (29-391-54) (March 10, 1986)
  • K860762 — GAMMA-FREE HORSE SERUM (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)

Other clearances for product code KEQ

  • K830515 — SCOTTS TAP WATER SUBSTITUTE CONCENTRATE (March 31, 1983)
  • K792709 — KOH MOUNTING FLUID W/GLYCEROL (January 24, 1980)
  • K792703 — LACTO-PHENOL ANALINE BLUE FLUID (January 24, 1980)
  • K792702 — VASPAR SEALANT (January 24, 1980)
  • K781868 — DROPPER, CEPTI-SEAL LAVTOPHENOL (November 22, 1978)
  • K781869 — DROPPER, CEPTI-SEAL KOH SOLUTION (November 22, 1978)

FDA data resources