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510(k) K972414

FRESHCELLS by Diagnostic Hybrids, Inc. — Product Code KIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1997
Date Received
June 27, 1997
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

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  • K090073 — D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (March 6, 2009)

Other clearances for product code KIR

  • K973213 — FRESH CELLS LLC-MK2 (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973212 — FRESH CELLS WI-38 (September 25, 1997)
  • K973214 — FRESH CELLS HFF (September 25, 1997)
  • K973209 — FRESH CELLS VERO (September 25, 1997)
  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K971508 — RHMK II CELL CULTURE, AN EXPANDED PRIMARY RHESUS MONKEY KIDNEY CELL CULTURE (September 17, 1997)
  • K965047 — MINK LUNG CELL CULTURE (February 4, 1997)
  • K962306 — FRESH CELLS MULTI-WELL & SHELL VIAL CULTURES (August 29, 1996)
  • K962782 — FRESHFROZEN CELLS, HEP-2 (August 29, 1996)