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510(k) K874887

WESBLOT PROCESSOR by American Bionetics, Inc. — Product Code KPA

K874887 is an FDA 510(k) premarket notification submitted by American Bionetics, Inc. for the device "WESBLOT PROCESSOR". The FDA issued a decision of Substantially Equivalent on March 24, 1988. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. American Bionetics, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1988
Date Received
December 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Slide Stainer, Automated
Device Class
Class I
Regulation Number
864.3800
Review Panel
PA
Submission Type

Other clearances by American Bionetics, Inc.

  • K884258 — VERSABLOT (December 14, 1988)
  • K881379 — WESBLOT RNP-SM TEST (May 16, 1988)

Other clearances for product code KPA

  • K933996 — PROFIBLOT (January 28, 1994)
  • K884258 — VERSABLOT (December 14, 1988)
  • K881592 — WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (May 13, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)
  • K874897 — SAKURA DRS-60 AUTOMATIC SLIDE STAINER (January 5, 1988)
  • K872916 — HISTOMATIC SLIDE STAINER, CODE-ON VERSION (September 14, 1987)
  • K853210 — MST-1050-II X-RAY UNIT (October 10, 1985)
  • K850157 — CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS (February 27, 1985)
  • K850333 — PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (February 27, 1985)
  • K842077 — MIDAS II AUTOMATIC STAINER (July 27, 1984)

FDA data resources