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510(k) K941872

SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 by Helena Laboratories — Product Code GGC

K941872 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302". The FDA issued a decision of Substantially Equivalent on November 21, 1994. The device falls under product code GGC (Control, Plasma, Abnormal), 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
November 21, 1994
Date Received
April 18, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Plasma, Abnormal
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Helena Laboratories

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  • 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 GGC

  • K102552 — HEMOSIL LA POSITIVE CONTROL (April 5, 2011)
  • K100103 — SPECIALTY ASSAYED CONTROL-2 (December 15, 2010)
  • K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 (March 16, 2007)
  • K061803 — STA - CONTROL LA 1+2 (July 28, 2006)
  • K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL (November 3, 2003)
  • K023312 — CONTROL PLASMA P (November 1, 2002)
  • K020878 — LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (April 15, 2002)
  • K020109 — SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (February 6, 2002)
  • K012422 — K-ASSAY D-DIMER CONTROLS (August 21, 2001)
  • K003329 — SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (March 1, 2001)

FDA data resources