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510(k) K812947

MONO-POLY RESOLVING MEDIUM by Flow Laboratories, Inc. — Product Code JCF

K812947 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "MONO-POLY RESOLVING MEDIUM". The FDA issued a decision of Substantially Equivalent on March 11, 1982. The device falls under product code JCF (Lymphocyte Separation Medium), a Class I device regulated under 21 CFR 864.8500. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 1982
Date Received
October 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lymphocyte Separation Medium
Device Class
Class I
Regulation Number
864.8500
Review Panel
HE
Submission Type

Other clearances by Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K862066 — TITERTEK MICROPLATE WASHER S-12 (June 5, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG 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)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)

Other clearances for product code JCF

  • K911731 — LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR (December 15, 1992)
  • K902445 — LYMPHO SEP(TM) (August 22, 1990)
  • K891407 — LEUCOPREP CELL SEPARATION TUBE (May 26, 1989)
  • K874328 — L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA (February 16, 1988)
  • K873185 — DYNABEADS HLA CELL PREP II ISOLATION PRODUCT (November 4, 1987)
  • K872775 — LEUCOPREP BRAND TUBE (October 2, 1987)
  • K860354 — SEPRACELL LYMPHOCYTE SEPARATION MEDIUM (April 18, 1986)
  • K854093 — LEUCO PREP (November 12, 1985)
  • K842818 — CST (October 23, 1984)
  • K842146 — HISTOPAQUE-1077 (July 27, 1984)

FDA data resources