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510(k) K891299

MID-LEVEL IGG KIT CAT. NO. 9315 by Helena Laboratories — Product Code DAQ

K891299 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "MID-LEVEL IGG KIT CAT. NO. 9315". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code DAQ (Igg (Fd Fragment Specific), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5540. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1989
Date Received
March 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Fd Fragment Specific), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5540
Review Panel
IM
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)

FDA data resources