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510(k) K853285

MYWASHER 5 by Scientific Sales Intl., Inc. — Product Code LIB

K853285 is an FDA 510(k) premarket notification submitted by Scientific Sales Intl., Inc. for the device "MYWASHER 5". The FDA issued a decision of Substantially Equivalent on October 4, 1985. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Scientific Sales Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
August 5, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Scientific Sales Intl., Inc.

  • K953677 — LIGHTED FLEXGUIDE (MODIFICATION) (August 25, 1995)
  • K940799 — FLEXGUIDE (August 18, 1994)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K862087 — SANTEST 1AP (December 3, 1986)
  • K861336 — IAP PLATE TEST (April 25, 1986)
  • K853284 — MYREADER 7 (October 4, 1985)
  • K853380 — SPR 2 AUTODILUTER (September 12, 1985)
  • K853379 — PLATE INCUBATOR (September 3, 1985)
  • K833022 — AIR UTERINE DISPLACER-AUD 120 (October 14, 1983)
  • K802416 — SALEM/RESCE INTUBATION GUIDE (October 23, 1980)

Other clearances for product code LIB

  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)
  • K920416 — SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (April 8, 1992)
  • K912558 — GULL ELISAWARE (September 16, 1991)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K871559 — CELL LIFTER (May 15, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)

FDA data resources