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510(k) K843375

ELVI 655 FLAME PHOTOMETER by Logos Scientific, Inc. — Product Code JJO

K843375 is an FDA 510(k) premarket notification submitted by Logos Scientific, Inc. for the device "ELVI 655 FLAME PHOTOMETER". The FDA issued a decision of Substantially Equivalent on May 20, 1985. The device falls under product code JJO (Flame Emission Photometer For Clinical Use), a Class I device regulated under 21 CFR 862.2540. Logos Scientific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1985
Date Received
August 28, 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 Logos Scientific, Inc.

  • K902614 — ELVI 828 DIGICLOT MULTISCAN (November 8, 1990)
  • K844710 — EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (January 7, 1985)
  • K843296 — ELVI 675 DIGITRON (September 13, 1984)
  • K842313 — ELVI 146 SEROSCAN (September 10, 1984)
  • K842056 — ELVI 165 PROTEO SEROSKOP (June 22, 1984)
  • K841804 — ELVI 70 SAFETY CHAMBER (May 31, 1984)
  • K840757 — ELVI 444 BILITRON (May 30, 1984)
  • K841288 — ELVI 18 (May 2, 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)
  • K841847 — LITHIUM REAGENT (August 17, 1984)
  • K834226 — FLAME PHOTOMETERS (June 22, 1984)
  • K841421 — DAILY WASH SOLUTION 5 (May 11, 1984)
  • K841422 — VOLUME TEST DYE 6 (May 11, 1984)
  • K840530 — SUPPLIES FOR INSTRUMENTATION LAB FLAME (March 30, 1984)
  • K840044 — SDI PREPAX DILUKIT 29-1000 (March 9, 1984)
  • K833535 — POTASSIUM SODIUM ANALYSIS PRODUCTS (December 29, 1983)
  • K832886 — FLAME PHOTOMETER T281-T282-T283 (December 8, 1983)

FDA data resources