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510(k) K771699

CARA-STAIN MODEL 3000 by American Safety Equipment Corp. — Product Code KPA

K771699 is an FDA 510(k) premarket notification submitted by American Safety Equipment Corp. for the device "CARA-STAIN MODEL 3000". The FDA issued a decision of Substantially Equivalent on September 13, 1977. The device falls under product code KPA (Slide Stainer, Automated), a Class I device regulated under 21 CFR 864.3800. American Safety Equipment Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1977
Date Received
September 6, 1977
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 Safety Equipment Corp.

  • K801010 — KIRSCHNER WIRE (May 20, 1980)
  • K760956 — SURGICAL MICRO DRILL (November 19, 1976)
  • K760960 — SURGICAL WIRE DRIVER (November 19, 1976)
  • K760958 — SURGICAL OSCILLATING SAW (November 16, 1976)
  • K760957 — SURGICAL RECIPROCATING SAW (November 15, 1976)
  • K760959 — SURGICAL CHISEL (November 15, 1976)

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)
  • K874887 — WESBLOT PROCESSOR (March 24, 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)

FDA data resources