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510(k) K863374

CODE-A-WELL SERIES 1-600, 1-625 by Plastic Injectors, Inc. — Product Code JTC

K863374 is an FDA 510(k) premarket notification submitted by Plastic Injectors, Inc. for the device "CODE-A-WELL SERIES 1-600, 1-625". The FDA issued a decision of Substantially Equivalent on September 11, 1986. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Plastic Injectors, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1986
Date Received
September 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Microtiter Diluting/Dispensing
Device Class
Class I
Regulation Number
866.2500
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)
  • 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)
  • K841390 — CODE-A-WELL (May 2, 1984)

Other clearances for product code JTC

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • K901808 — MICROMATE 196 MODEL A961960 (June 20, 1990)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K892369 — MULTI-PROBE HEAD PLUS (June 2, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (May 1, 1989)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (May 1, 1989)
  • K884695 — WASHER 500 MICROELISA SYSTEM (December 13, 1988)
  • K884125 — BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (December 2, 1988)
  • K874598 — DYNATECH MR 250 MANUAL MICROELISA READER (November 20, 1987)

FDA data resources