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510(k) K841390

CODE-A-WELL by Plastic Injectors, Inc. — Product Code LIB

K841390 is an FDA 510(k) premarket notification submitted by Plastic Injectors, Inc. for the device "CODE-A-WELL". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Plastic Injectors, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
April 3, 1984
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 Plastic Injectors, Inc.

  • K884781 — OPTI-POINT (January 12, 1989)
  • K863423 — CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 (September 16, 1986)
  • K863374 — CODE-A-WELL SERIES 1-600, 1-625 (September 11, 1986)
  • K844058 — CODE-A-WALL SERIES 1-250 INOCULUM TRAY (November 13, 1984)
  • K842848 — CODE-A-WELL 350 MICROTITRATION STRIPS (September 7, 1984)
  • K841632 — CODE-A-WELL SERIES 200 PLATE (May 25, 1984)
  • K841937 — CODE-A-WELL SERIES 300 PLATE (May 22, 1984)

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)
  • K854603 — MULTI MASH 2000 (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)

FDA data resources