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510(k) K772245

HAPTOGLOBIN NEPHELOMETRIC ASSAY by Kallestad Laboratories, Inc. — Product Code DAD

K772245 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "HAPTOGLOBIN NEPHELOMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on December 22, 1977. The device falls under product code DAD (Haptoglobin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5460. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1977
Date Received
December 9, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Haptoglobin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5460
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)
  • K855011 — QUANTIMETRIC PLUS C3 REAGENT KIT (February 26, 1986)
  • K855008 — QUANTIMETRIC PLUS KAPPA REAGENT KIT (February 26, 1986)

Other clearances for product code DAD

  • K993480 — K-ASSAY HAPTOGLOBIN (November 24, 1999)
  • K972639 — TINA-QUANT HAPTOGLOBIN (January 9, 1998)
  • K964301 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K963286 — IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (October 7, 1996)
  • K952593 — N/T PROTEIN CONTROL SY/L, M AND H (July 17, 1995)
  • K915829 — IL TEST(TM) HAPTOGLOBIN (HPT) (July 29, 1992)
  • K911898 — RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT (May 8, 1991)
  • K890562 — SPQ(TM) ANTIBODY REAGENT SET II FOR HPT (February 22, 1989)
  • K873866 — HAPTOGLOBIN (October 20, 1987)
  • K872717 — QM300 HAPTOGLOBIN ANTIBODY PACK (July 21, 1987)

FDA data resources