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510(k) K965047

MINK LUNG CELL CULTURE by Neogenex — Product Code KIR

K965047 is an FDA 510(k) premarket notification submitted by Neogenex for the device "MINK LUNG CELL CULTURE". The FDA issued a decision of Substantially Equivalent on February 4, 1997. 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
February 4, 1997
Date Received
December 18, 1996
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

  • K960909 — H292 CELL CULTURE (May 30, 1996)
  • K943891 — RD CULTURE CELL (November 28, 1994)
  • K943890 — WI38 CELL CULTURE (November 28, 1994)
  • 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)
  • K943886 — BGM CELL CULTURE (November 28, 1994)
  • K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE (November 28, 1994)
  • K941714 — CHLAMYDIA TRACHOMATIS ANTIGEN TEST (July 18, 1994)

Other clearances for product code KIR

  • K973209 — FRESH CELLS VERO (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K973214 — FRESH CELLS HFF (September 25, 1997)
  • K973212 — FRESH CELLS WI-38 (September 25, 1997)
  • K973213 — FRESH CELLS LLC-MK2 (September 25, 1997)
  • K971508 — RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (September 17, 1997)
  • K972414 — FRESHCELLS (August 29, 1997)
  • K962780 — FRESHCELLS, HEP-2 (August 29, 1996)
  • K962782 — FRESHFROZEN CELLS, HEP-2 (August 29, 1996)

FDA data resources