Home / 510(k) Clearances / K790588

510(k) K790588

ASSAY REAGENTS, LSA 290 by Kallestad Laboratories, Inc. — Product Code JEW

K790588 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "ASSAY REAGENTS, LSA 290". The FDA issued a decision of Substantially Equivalent on May 15, 1979. The device falls under product code JEW (Tip, Rubber, Oral Hygiene), a Class I device regulated under 21 CFR 872.6650. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1979
Date Received
March 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tip, Rubber, Oral Hygiene
Device Class
Class I
Regulation Number
872.6650
Review Panel
DE
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)
  • K855008 — QUANTIMETRIC PLUS KAPPA REAGENT KIT (February 26, 1986)
  • K855007 — QUANTIMETRIC PLUS LAMBDA REAGENT KIT (February 26, 1986)

Other clearances for product code JEW

  • K862635 — RABINOWITZ GUM MASSAGER (September 25, 1986)
  • K843406 — CHEW-DENT (December 11, 1984)

FDA data resources