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510(k) K010617

SPIFE IFE CALIBRATOR AND CONTROL KIT by Helena Laboratories — Product Code DEW

K010617 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "SPIFE IFE CALIBRATOR AND CONTROL KIT". The FDA issued a decision of Substantially Equivalent on March 15, 2001. The device falls under product code DEW (Igg, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2001
Date Received
March 1, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
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 DEW

  • K050113 — TINA-QUANT IGG GEN.2 (February 8, 2005)
  • K040434 — ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (March 10, 2004)
  • K993928 — WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (January 18, 2000)
  • K993281 — K-ASSAY IGG (November 9, 1999)
  • K983221 — IGG (November 4, 1998)
  • K965108 — SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (March 6, 1997)
  • K963974 — IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (March 6, 1997)
  • K963868 — IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (February 10, 1997)
  • K962202 — QUANTEX IGG (September 26, 1996)
  • K955798 — IGG IMMUNOTURBIDIMETRIC & CALIBRATOR (April 5, 1996)

FDA data resources