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510(k) K842485

OPTICLEAR by Gelman Sciences, Inc. — Product Code JJN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
June 25, 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

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  • K910821 — TRANSDUCER PROTECTOR (August 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (June 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
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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)