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510(k) K841345

ULTRACLONE ECL-01-500 CELL LINE by Earl-Clay Laboratories, Inc. — Product Code KIR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1984
Date Received
April 2, 1984
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 Earl-Clay Laboratories, Inc.

  • K861585 — ULTRACLONE 01-2300 CELL LINE (May 13, 1986)
  • K861569 — ULTRACLONE 01-700 CELL LINE (May 5, 1986)
  • K854206 — ULTRACLONE 05-100 GUINEA PIG RBC (October 31, 1985)
  • K853203 — ULTRACLONE ECL-01-2200 CELL LINE (August 12, 1985)
  • K851545 — ULTRACLONE ECL-01-800 CELL LINE (May 10, 1985)
  • K843579 — ULTRACLONE ECL-01-1100 (October 31, 1984)
  • K843578 — ULTRACLONE ECL-01-2100 CELL LINE (October 31, 1984)
  • K843577 — ULTRAXLONE ECL-01-1000 CELL LINE (October 31, 1984)
  • K843862 — ULTRACLONE ECL-01-900 CELL LINE (October 17, 1984)
  • K843863 — ULTRACLONE ECL-01-1300 CELL LINE (October 17, 1984)

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  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973213 — FRESH CELLS LLC-MK2 (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)