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510(k) K811775

KALLESTAD ANTISERA TO PHENYTOIN by Kallestad Laboratories, Inc. — Product Code DLP

K811775 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "KALLESTAD ANTISERA TO PHENYTOIN". The FDA issued a decision of Substantially Equivalent on July 10, 1981. The device falls under product code DLP (Radioimmunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1981
Date Received
June 23, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
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 DLP

  • K894527 — FPR PHENYTOIN KIT (September 25, 1989)
  • K792640 — FLUOROMATIC PHENYTOIN FIA (January 11, 1980)
  • K791896 — CENTRIA PHENYTOIN RIA TEST SET (October 17, 1979)
  • K770779 — PHENYTOIN RIA KIT (June 17, 1977)

FDA data resources