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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 October 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
October 10, 1980
Date Received
July 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 (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 JCA

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

FDA data resources