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510(k) K842560

OPTIPHOR-10 by Gelman Sciences, Inc. — Product Code JJN

K842560 is an FDA 510(k) premarket notification submitted by Gelman Sciences, Inc. for the device "OPTIPHOR-10". The FDA issued a decision of Substantially Equivalent on Aug 10, 1984. The device falls under product code JJN (Apparatus, Electrophoresis, For Clinical Use), a Class I device regulated under 21 CFR 862.2485. Gelman Sciences, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 10, 1984
Date Received
Jul 2, 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 Gelman Sciences, Inc.

  • K946190 — DRUG DISPENSING SPIKE (Mar 17, 1995)
  • K943127 — PHARMASSURE LARGE VOLUME TRANSFER FILTERS (Sep 29, 1994)
  • K941589 — SYRINGE FILTER DEVICES (Sep 6, 1994)
  • K941020 — DRUG RECONSTITUTION FILTER DEVICE (Aug 10, 1994)
  • K942275 — VIAL VENT FILTER (Jul 26, 1994)
  • K941032 — UNKNOWN (May 27, 1994)
  • K910821 — TRANSDUCER PROTECTOR (Aug 12, 1991)
  • K892387 — MODIFIED GELMAN ARTERIAL FILTER (Jun 22, 1989)
  • K884176 — CHROMATOGRAPHY KIT (Apr 4, 1989)
  • K884177 — DRUG STANDARD SET (Feb 17, 1989)

Other clearances for product code JJN

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

FDA data resources