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510(k) K933924

MCCOY CULTURE CELL by Neogenex — Product Code KIR

K933924 is an FDA 510(k) premarket notification submitted by Neogenex for the device "MCCOY CULTURE CELL". The FDA issued a decision of Substantially Equivalent on Mar 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 19 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 29, 1994
Date Received
Aug 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
510(k) Exempt

Other clearances by Neogenex

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

Other clearances for product code KIR

  • K973209 — FRESH CELLS VERO (Sep 25, 1997)
  • K973211 — FRESH CELLS MV1LU (Sep 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (Sep 25, 1997)
  • K973214 — FRESH CELLS HFF (Sep 25, 1997)
  • K973212 — FRESH CELLS WI-38 (Sep 25, 1997)
  • K973213 — FRESH CELLS LLC-MK2 (Sep 25, 1997)
  • K971508 — RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (Sep 17, 1997)
  • K972414 — FRESHCELLS (Aug 29, 1997)
  • K965047 — MINK LUNG CELL CULTURE (Feb 4, 1997)
  • K962782 — FRESHFROZEN CELLS, HEP-2 (Aug 29, 1996)

FDA data resources

Source: FDA 510(k) database entry for K933924. Report a data issue: hello@regdatalab.com.