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510(k) K821517

TITANAN GEL SERUM PROTEIN ELECTROPHORES by Helena Laboratories — Product Code JJN

K821517 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITANAN GEL SERUM PROTEIN ELECTROPHORES". The FDA issued a decision of Substantially Equivalent on June 10, 1982. The device falls under product code JJN (Apparatus, Electrophoresis, For Clinical Use), a Class I device regulated under 21 CFR 862.2485. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1982
Date Received
May 21, 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 Helena Laboratories

  • K213396 — SPIFE A1AT kit (October 13, 2022)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K131479 — V8 SP NORMAL CONTROL, ABNORMAL CONTROL (October 7, 2013)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (February 23, 2007)
  • K061069 — SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, S (July 6, 2006)
  • K061014 — ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP (May 10, 2006)
  • K050053 — HEMORAM/AGGRAM ANALYZER (July 11, 2005)
  • K024162 — SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 (February 19, 2003)
  • K023761 — PLATELETWORKS, MODELS PW-A, PW-C (February 14, 2003)

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