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510(k) K061991

PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA by Helena Laboratories — Product Code GHR

K061991 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA". The FDA issued a decision of Substantially Equivalent on February 23, 2007. The device falls under product code GHR (Reagent, Platelet Aggregation), a Class II device regulated under 21 CFR 864.5700. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2007
Date Received
July 13, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Platelet Aggregation
Device Class
Class II
Regulation Number
864.5700
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)
  • 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)
  • K022757 — SPIFE CK KIT, MODEL 3332, 3333 (October 11, 2002)

Other clearances for product code GHR

  • K952252 — ADP REAGENT, MODIFIED (September 8, 1995)
  • K922800 — PLATELET AGGREGATION REAGENTS (August 26, 1992)
  • K910800 — ADP REAGENT (May 20, 1991)
  • K910706 — COLLAGEN REAGENT CAT. NO. 5368 (May 20, 1991)
  • K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367 (May 20, 1991)
  • K910286 — PLATELET AGGREGATION REAGENTS (March 19, 1991)
  • K900792 — RISTOCETIN (March 27, 1990)
  • K832428 — PLATELET AGGREGATION REAGENT SET (October 20, 1983)
  • K820422 — PLATELET AGGREGOMETERS (March 16, 1982)
  • K760198 — KIT, PLATELET AGGREGATION REAGENT (#390) (July 19, 1976)

FDA data resources