Home / 510(k) Clearances / K811445

510(k) K811445

KALLESTAD R QUANTIPLATE ALT. PATHWAY T. by Kallestad Laboratories, Inc. — Product Code DHL

K811445 is an FDA 510(k) premarket notification submitted by Kallestad Laboratories, Inc. for the device "KALLESTAD R QUANTIPLATE ALT. PATHWAY T.". The FDA issued a decision of Substantially Equivalent on June 24, 1981. The device falls under product code DHL (Protein, Complement, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.4100. Kallestad Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1981
Date Received
May 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protein, Complement, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.4100
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)
  • K855013 — QUANTIMETRIC PLUS SUPPORT PACK (February 26, 1986)
  • K855011 — QUANTIMETRIC PLUS C3 REAGENT KIT (February 26, 1986)

Other clearances for product code DHL

  • K870351 — EZ COMPLEMENT REAGENTS, 78N2212 (March 13, 1987)
  • K811433 — SCRIPPSERA COMPLEMENT CONTROL SERA (June 16, 1981)
  • K770866 — RABBIT COMPLEMENT (June 3, 1977)

FDA data resources