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510(k) K801815

AUTOLET by Ulster Scientific, Inc. — Product Code JCA

K801815 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "AUTOLET". The FDA issued a decision of Substantially Equivalent on Oct 10, 1980. The device falls under product code JCA (Device, Bleeding Time), a Class II device regulated under 21 CFR 864.6100. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 10, 1980
Date Received
Jul 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Bleeding Time
Device Class
Class II
Regulation Number
864.6100
Review Panel
HE
Submission Type

Other clearances by Ulster Scientific, Inc.

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

Other clearances for product code JCA

  • K911745 — SIMPLATE PEDIATRIC (Aug 9, 1991)
  • K911996 — SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION (Jul 17, 1991)
  • K871318 — Q.I.C. BLEEDING TIME DEVICE (Jun 10, 1987)
  • K850542 — SURGICUTT - BLEEDING TIME DEVICE (Mar 1, 1985)
  • K830645 — BLEEDING TIME DEVICE DISPOSABLE (Mar 17, 1983)
  • K761250 — SIMPLATE (Mar 1, 1977)

FDA data resources