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510(k) K823132

SARTOPHOR SYSTEM FOR ELECTROPHORESIS by Sartorius Filters, Inc. — Product Code JJN

K823132 is an FDA 510(k) premarket notification submitted by Sartorius Filters, Inc. for the device "SARTOPHOR SYSTEM FOR ELECTROPHORESIS". The FDA issued a decision of Substantially Equivalent on November 27, 1982. The device falls under product code JJN (Apparatus, Electrophoresis, For Clinical Use), a Class I device regulated under 21 CFR 862.2485. Sartorius Filters, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1982
Date Received
October 25, 1982
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 Sartorius Filters, Inc.

  • K851816 — SARTORIUS MINISART FH 16534 (August 19, 1985)
  • K851818 — SARTORIUS MINI SART FH 16592 (August 19, 1985)
  • K851817 — SARTORIUS MINI-SART FH 16555 (August 19, 1985)
  • K850435 — SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (June 4, 1985)
  • K844504 — SARTORIUS MINISART SM 16596HY (January 18, 1985)
  • K830487 — HEMO-PROCESSING SYSTEM (April 28, 1983)
  • K822285 — CELLULOSE ACETATE MEMBRANE STRIPS (September 21, 1982)

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