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510(k) K912201

PACKS-4 (TM) ANALYZER by Helena Laboratories — Product Code JBY

K912201 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "PACKS-4 (TM) ANALYZER". The FDA issued a decision of Substantially Equivalent on August 16, 1991. The device falls under product code JBY (Aggregometer, Platelet, Photo-Optical Scanning), a Class II device regulated under 21 CFR 864.6675. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1991
Date Received
May 20, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aggregometer, Platelet, Photo-Optical Scanning
Device Class
Class II
Regulation Number
864.6675
Review Panel
HE
Submission Type

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  • 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 JBY

  • K771198 — LUMI-AGGREGOMETER (August 2, 1977)

FDA data resources