Home / 510(k) Clearances / K944698

510(k) K944698

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 by Organon Teknika Corp. — Product Code CFT

K944698 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1". The FDA issued a decision of Substantially Equivalent on March 21, 1995. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1995
Date Received
September 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Prolactin (Lactogen)
Device Class
Class I
Regulation Number
862.1625
Review Panel
CH
Submission Type

Other clearances by Organon Teknika Corp.

  • K003104 — BACT/ALERT CSR (October 20, 2000)
  • K000492 — MDA D-DIMER (June 7, 2000)
  • K000378 — BACT/ALERT MB CULTURE BOTTLE (March 2, 2000)
  • K994343 — BACT/ALERT SV (February 10, 2000)
  • K993423 — BACT/ALERT SA (December 15, 1999)
  • K993421 — BACT/ALERT SN (December 14, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (December 14, 1999)
  • K992432 — BACT/ALERT FN (September 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992401 — BACT/ALERT PF (September 3, 1999)

Other clearances for product code CFT

  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (February 25, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K964748 — ELECSYS PROLACTIN ASSAY (January 21, 1997)
  • K960561 — DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (April 26, 1996)
  • K960060 — DSL ACTIVE PROLACTIN IRMA (February 29, 1996)
  • K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION) (October 20, 1995)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K943811 — ENZYME-LINKED FLUORESCENT IMMUNOASSAY (November 2, 1994)

FDA data resources