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510(k) K843864

ULTRACLONE ECL-01-1400 CELL LINE by Earl-Clay Laboratories, Inc. — Product Code KIT

K843864 is an FDA 510(k) premarket notification submitted by Earl-Clay Laboratories, Inc. for the device "ULTRACLONE ECL-01-1400 CELL LINE". The FDA issued a decision of Substantially Equivalent on October 17, 1984. The device falls under product code KIT (Media And Components, Synthetic Cell And Tissue Culture), a Class I device regulated under 21 CFR 864.2220. Earl-Clay Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1984
Date Received
October 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
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)
  • K843863 — ULTRACLONE ECL-01-1300 CELL LINE (October 17, 1984)
  • K843862 — ULTRACLONE ECL-01-900 CELL LINE (October 17, 1984)

Other clearances for product code KIT

  • K892938 — AMNIO-GROW TM (May 22, 1989)
  • K890701 — ENDOTHELIAL GROWTH MEDIUM (EGM) (February 24, 1989)
  • K890700 — MELANOCYTE GROWTH MEDIUM (MGM) (February 24, 1989)
  • K890482 — ABC, ABC-1X, ABC(TM) (February 10, 1989)
  • K884654 — ALPHACALF SERUM (November 30, 1988)
  • K884573 — HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 (November 22, 1988)
  • K884574 — DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 (November 22, 1988)
  • K884572 — RPMI-1640 HYBRI-MAX, PROD. NO. R5382 (November 22, 1988)
  • K883065 — ALLOPREP SYSTEM (October 13, 1988)
  • K884031 — FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT (October 6, 1988)

FDA data resources