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510(k) K833358

MRC-5 CELLS by Biocon, Inc. — Product Code KIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
September 28, 1983
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 Biocon, Inc.

  • K833360 — HEP-2 CELLS (November 3, 1983)
  • K833359 — WI-38 CELLS (November 3, 1983)

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  • 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)
  • K962306 — FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (August 29, 1996)