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510(k) K934973

HELA-229/HELA CELLS by Advanced Clinical Diagnostics — Product Code KIR

K934973 is an FDA 510(k) premarket notification submitted by Advanced Clinical Diagnostics for the device "HELA-229/HELA CELLS". The FDA issued a decision of Substantially Equivalent on January 28, 1994. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Advanced Clinical Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1994
Date Received
October 18, 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 Advanced Clinical Diagnostics

  • K936171 — TRANSFORMED PRIMARY HUMAN EMBRYONAL KIDNEY (February 3, 1994)
  • K936169 — RHESUS MONKEY KIDNEY CELLS (February 3, 1994)
  • K936172 — RHESUS MONKEY KIDNEY CELLS (LLC-MK2) (February 3, 1994)
  • K934934 — RABBIT KIDNEY CELLS - R.K.C. (January 28, 1994)
  • K935766 — PRIMARY AFRICAN GREEN MONKEY KIDNEY CELLS (January 24, 1994)
  • K934240 — KIDNEY AFRICIAN GREEN MONKEY CELLS-VERO (January 3, 1994)
  • K934241 — MCCOY CULTURE CELLS-MCCOY (January 3, 1994)
  • K935338 — LUNG CACINOMA, HUMAN CELLS (January 3, 1994)
  • K934246 — LUNG DIPLOID HUMAN CELLS-WI-38 (January 3, 1994)
  • K935339 — HELA HELA EPITHELOID CARCINOMA (January 3, 1994)

Other clearances for product code KIR

  • K973212 — FRESH CELLS WI-38 (September 25, 1997)
  • K973213 — FRESH CELLS LLC-MK2 (September 25, 1997)
  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973209 — FRESH CELLS VERO (September 25, 1997)
  • K973214 — FRESH CELLS HFF (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)
  • K962782 — FRESHFROZEN CELLS, HEP-2 (August 29, 1996)

FDA data resources