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510(k) K843579

ULTRACLONE ECL-01-1100 by Earl-Clay Laboratories, Inc. — Product Code KIR

K843579 is an FDA 510(k) premarket notification submitted by Earl-Clay Laboratories, Inc. for the device "ULTRACLONE ECL-01-1100". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code KIR (Cells, Animal And Human, Cultured), a Class I device regulated under 21 CFR 864.2280. Earl-Clay Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
September 11, 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)
  • K843577 — ULTRAXLONE ECL-01-1000 CELL LINE (October 31, 1984)
  • K843578 — ULTRACLONE ECL-01-2100 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)
  • K843864 — ULTRACLONE ECL-01-1400 CELL LINE (October 17, 1984)

Other clearances for product code KIR

  • K973209 — FRESH CELLS VERO (September 25, 1997)
  • K973210 — FRESH CELLS NCI H292 (September 25, 1997)
  • K973211 — FRESH CELLS MV1LU (September 25, 1997)
  • K973214 — FRESH CELLS HFF (September 25, 1997)
  • K973212 — FRESH CELLS WI-38 (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)
  • K962780 — FRESHCELLS, HEP-2 (August 29, 1996)

FDA data resources