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510(k) K810475

HELENA HEMOGLOBIN F CONTROLS by Helena Laboratories — Product Code KQI

K810475 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "HELENA HEMOGLOBIN F CONTROLS". The FDA issued a decision of Substantially Equivalent on March 26, 1981. The device falls under product code KQI (Assay, Fetal Hemoglobin), a Class II device regulated under 21 CFR 864.7455. Helena Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1981
Date Received
February 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Fetal Hemoglobin
Device Class
Class II
Regulation Number
864.7455
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 KQI

  • K880653 — HBF DILUENT (April 21, 1988)
  • K812226 — HELENA HBF QUIPLATE CONTROL (September 1, 1981)
  • K791143 — SICKLE-CELL F TEST (July 17, 1979)

FDA data resources