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510(k) K933923

A549 CULTURE CELL by Neogenex — Product Code KIR

K933923 is an FDA 510(k) premarket notification submitted by Neogenex for the device "A549 CULTURE CELL". The FDA issued a decision of Substantially Equivalent on March 29, 1994. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Neogenex has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1994
Date Received
August 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cells, Animal And Human, Cultured
Device Class
Class I
Regulation Number
864.2280
Review Panel
PA
Submission Type

Other clearances by Neogenex

  • K965047 — MINK LUNG CELL CULTURE (February 4, 1997)
  • K960909 — H292 CELL CULTURE (May 30, 1996)
  • K943884 — PRIMARY MONKEY KIDNEY CELL CULTURE (November 28, 1994)
  • K943888 — MDCK CELL CULTURE (November 28, 1994)
  • K943889 — VERO CELL CULTURE (November 28, 1994)
  • K943887 — HUMAN NEWBORN FORESKIN CELL CULTURE (November 28, 1994)
  • K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE (November 28, 1994)
  • K943890 — WI38 CELL CULTURE (November 28, 1994)
  • K943891 — RD CULTURE CELL (November 28, 1994)
  • K943886 — BGM CELL CULTURE (November 28, 1994)

Other clearances for product code KIR

  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K973213 — FRESH CELLS LLC-MK2 (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973214 — FRESH CELLS HFF (September 25, 1997)
  • K973212 — FRESH CELLS WI-38 (September 25, 1997)
  • K973209 — FRESH CELLS VERO (September 25, 1997)
  • K971508 — RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (September 17, 1997)
  • K972414 — FRESHCELLS (August 29, 1997)
  • K965047 — MINK LUNG CELL CULTURE (February 4, 1997)
  • K962306 — FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (August 29, 1996)

FDA data resources