Home / 510(k) Clearances / K831603

510(k) K831603

TITAN GE/IEPLATE by Helena Laboratories — Product Code JZR

K831603 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "TITAN GE/IEPLATE". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code JZR (Support Gels), a Class I device regulated under 21 CFR 866.4900. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
May 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support Gels
Device Class
Class I
Regulation Number
866.4900
Review Panel
IM
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 JZR

  • K940037 — I.D. AND SEAKEM GTG AGAROSES (February 24, 1995)

FDA data resources