Home / 510(k) Clearances / K840044

510(k) K840044

SDI PREPAX DILUKIT 29-1000 by Scientific Distributors, Inc. — Product Code JJO

K840044 is an FDA 510(k) premarket notification submitted by Scientific Distributors, Inc. for the device "SDI PREPAX DILUKIT 29-1000". The FDA issued a decision of Substantially Equivalent on March 9, 1984. The device falls under product code JJO (Flame Emission Photometer For Clinical Use), a Class I device regulated under 21 CFR 862.2540. Scientific Distributors, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1984
Date Received
January 6, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Emission Photometer For Clinical Use
Device Class
Class I
Regulation Number
862.2540
Review Panel
CH
Submission Type

Other clearances by Scientific Distributors, Inc.

  • K892658 — SDI PREPAX COUNTAPETTE KIT (May 24, 1989)
  • K851320 — SDI PREPAX DILUKIT M. (July 5, 1985)
  • K840041 — SDI PREPAX DILUKIT HW (March 5, 1984)
  • K840042 — SDI PREPAX DILUKIT CA (February 10, 1984)
  • K840043 — SDI PREPAX DILUKIT CT (February 10, 1984)
  • K840038 — PREPAX DILUKIT PLUS (February 10, 1984)

Other clearances for product code JJO

  • K873603 — FINNIGAN MAT INCOS 50 (September 22, 1987)
  • K862148 — OLYMPUS AU 5000 FLAME PHOTOMETER MODULE (September 29, 1986)
  • K843375 — ELVI 655 FLAME PHOTOMETER (May 20, 1985)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K834226 — FLAME PHOTOMETERS (June 22, 1984)
  • K841422 — VOLUME TEST DYE 6 (May 11, 1984)
  • K841421 — DAILY WASH SOLUTION 5 (May 11, 1984)
  • K840530 — SUPPLIES FOR INSTRUMENTATION LAB FLAME (March 30, 1984)
  • K833535 — POTASSIUM SODIUM ANALYSIS PRODUCTS (December 29, 1983)
  • K832886 — FLAME PHOTOMETER T281-T282-T283 (December 8, 1983)

FDA data resources