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510(k) K821862

QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. by Kallestad Laboratories, Inc. — Product Code LCA

K821862 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.". The FDA issued a decision of Substantially Equivalent on July 6, 1982. The device falls under product code LCA (Radioimmunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1982
Date Received
June 24, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
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 LCA

  • K880291 — THEOPHYLLINE TEST KIT REF. #A874799 (March 24, 1988)
  • K833789 — PHASE II THEOPHYLLINE RADIOIMMUNOASSAY (January 24, 1984)
  • K821347 — BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (May 28, 1982)
  • K792062 — THEOPHYLLINE RIASSAY (February 25, 1980)

FDA data resources