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510(k) K941737

SPECIALTY ASSAYED CONTROL-1 by Helena Laboratories — Product Code GIZ

K941737 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "SPECIALTY ASSAYED CONTROL-1". The FDA issued a decision of Substantially Equivalent on October 7, 1994. The device falls under product code GIZ (Plasma, Control, Normal), a Class II device regulated under 21 CFR 864.5425. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1994
Date Received
April 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Control, Normal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
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 GIZ

  • K060968 — STASIS - I, II AND III; SERATHAN - A, B; INTRIN - EA, SI CALCIUM CHLORIDE 0.02M; (May 15, 2007)
  • K042941 — DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS (December 2, 2004)
  • K023309 — CONTROL PLASMA N (November 1, 2002)
  • K013708 — REFERENCE CHECK, CATALOG NUMBER-RCN-10 (December 10, 2001)
  • K003328 — ACCUCLOT CONTROL I, MODEL A4089 (March 1, 2001)
  • K001256 — CONTROL PLASMA N (May 24, 2000)
  • K984129 — COAGULATION CONTROL LEVEL 1 (NORMAL) (December 1, 1998)
  • K973274 — ACCUCOLOR HIGH CALIBRATOR (A3089) (October 31, 1997)
  • K961814 — THROMBOLYTIC ASSESSMENT SYSTEM PROTHROMBIN TIME TEST CONTROLS (August 13, 1996)
  • K935254 — DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA (September 19, 1994)

FDA data resources