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510(k) K943884

PRIMARY MONKEY KIDNEY CELL CULTURE by Neogenex — Product Code KIR

K943884 is an FDA 510(k) premarket notification submitted by Neogenex for the device "PRIMARY MONKEY KIDNEY CELL CULTURE". The FDA issued a decision of Substantially Equivalent on November 28, 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
November 28, 1994
Date Received
August 9, 1994
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)
  • K943890 — WI38 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)
  • K943891 — RD CULTURE CELL (November 28, 1994)
  • K943885 — PRIMARY RABBIT KIDNEY CELL CULTURE (November 28, 1994)
  • K943886 — BGM 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)
  • K973213 — FRESH CELLS LLC-MK2 (September 25, 1997)
  • K973214 — FRESH CELLS HFF (September 25, 1997)
  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973212 — FRESH CELLS WI-38 (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)
  • K962780 — FRESHCELLS, HEP-2 (August 29, 1996)

FDA data resources