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510(k) K780250

HEMOPEXIN NEPHELOMETRIC ASSAYS by Kallestad Laboratories, Inc. — Product Code CZX

K780250 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "HEMOPEXIN NEPHELOMETRIC ASSAYS". The FDA issued a decision of Substantially Equivalent on February 28, 1978. The device falls under product code CZX (Hemopexin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5490. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1978
Date Received
February 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemopexin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5490
Review Panel
IM
Submission Type

Other clearances by Kallestad Laboratories, Inc.

  • K863681 — PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM (December 3, 1986)
  • K862917 — PATHFINDER ROTAVIRUS CHEMILUMINESCENT (October 22, 1986)
  • K863682 — PATHFINDER(TM) SPECIMEN COLLECTION KIT (October 10, 1986)
  • K862743 — PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS (September 29, 1986)
  • K862313 — KALLESTAD SM/RNP TEST REAGENT (August 6, 1986)
  • K862710 — KALLESTAD SSA/SSB ENA TEST REAGENTS (July 29, 1986)
  • K855014 — QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A (March 14, 1986)
  • K855010 — QUANTIMETRIC PLUS IGM REAGENT KIT (February 28, 1986)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)
  • K855013 — QUANTIMETRIC PLUS SUPPORT PACK (February 26, 1986)

Other clearances for product code CZX

  • K801432 — HEMOPEXIN NEPHELOMETRIC ASSAY (July 8, 1980)
  • K790713 — ANTISERUM TO HUMAN HEMOPEXIN (September 4, 1979)

FDA data resources