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510(k) K842517

UNILET LANCET by Ulster Scientific, Inc. — Product Code FML

K842517 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "UNILET LANCET". The FDA issued a decision of Substantially Equivalent on September 20, 1984. The device falls under product code FML (Chair, Blood Donor), a Class I device regulated under 21 CFR 880.6140. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Blood Donor
Device Class
Class I
Regulation Number
880.6140
Review Panel
HO
Submission Type

Other clearances by Ulster Scientific, Inc.

  • K942620 — FEATHER-TOUCH SINGLE-STICK DEVICE (June 22, 1994)
  • K920562 — UNISTIK (March 27, 1992)
  • K902592 — EPC ELECTRONIC PIPETTING SYSTEM (July 19, 1990)
  • K895890 — AUTOPEN (February 16, 1990)
  • K894474 — THE AUTOLET LITE (August 18, 1989)
  • K885340 — AIR DISPLACEMENT PIPETTE (February 14, 1989)
  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (February 17, 1988)
  • K871571 — NEUROTIPS(TM) (June 18, 1987)
  • K871076 — WINPETTE (March 23, 1987)
  • K870078 — ACCUPEN(R) (March 17, 1987)

Other clearances for product code FML

  • K780181 — GLOVES, FLOOR (February 21, 1978)

FDA data resources