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510(k) K841288

ELVI 18 by Logos Scientific, Inc. — Product Code JJN

K841288 is an FDA 510(k) premarket notification submitted by Logos Scientific, Inc. for the device "ELVI 18". The FDA issued a decision of Substantially Equivalent on May 2, 1984. The device falls under product code JJN (Apparatus, Electrophoresis, For Clinical Use), a Class I device regulated under 21 CFR 862.2485. Logos Scientific, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1984
Date Received
March 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrophoresis, For Clinical Use
Device Class
Class I
Regulation Number
862.2485
Review Panel
CH
Submission Type

Other clearances by Logos Scientific, Inc.

  • K902614 — ELVI 828 DIGICLOT MULTISCAN (November 8, 1990)
  • K843375 — ELVI 655 FLAME PHOTOMETER (May 20, 1985)
  • 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)

Other clearances for product code JJN

  • K924021 — POWER SUPPLY (January 28, 1993)
  • K924020 — ELECTROPHORESIS TANK (December 28, 1992)
  • K882344 — ELECTR-TRANSBLOTTER (January 13, 1989)
  • K881852 — REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 (July 8, 1988)
  • K882163 — HELENA REP GEL PROCESSOR (June 20, 1988)
  • K873352 — RAPID ELECTROPHORESIS SYSTEM (REP) (September 8, 1987)
  • K864436 — STAVIP 3000 (March 16, 1987)
  • K861414 — ELECTROPHORESIS WORK CENTER (EWC) (August 26, 1986)
  • K841407 — ISOGEL AGAROSE (July 16, 1985)
  • K844710 — EUROCHIMA SERUM PROTEIN ELECTROPHORESIS METHOD (January 7, 1985)

FDA data resources