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510(k) K834226

FLAME PHOTOMETERS by Dr. Bruno Lange GmbH — Product Code JJO

K834226 is an FDA 510(k) premarket notification submitted by Dr. Bruno Lange GmbH for the device "FLAME PHOTOMETERS". The FDA issued a decision of Substantially Equivalent on June 22, 1984. The device falls under product code JJO (Flame Emission Photometer For Clinical Use), a Class I device regulated under 21 CFR 862.2540. Dr. Bruno Lange GmbH has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1984
Date Received
December 6, 1983
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 Dr. Bruno Lange GmbH

  • K832531 — PHOTOMETER LP 300 (December 12, 1983)
  • K801564 — PHOTOMETER LP 1 (August 20, 1980)
  • K801562 — PHOTOMETER LP 6 (August 20, 1980)
  • K801563 — PHOTOMETER LP 3 (August 20, 1980)

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)
  • 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)
  • 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