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510(k) K883269

PRL-QUANT by Leeco Diagnostics, Inc. — Product Code CFT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1988
Date Received
August 3, 1988
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 Leeco Diagnostics, Inc.

  • K895765 — LEECO PREVIEW(R) EBV (EIA) (October 31, 1989)
  • K894122 — LEECO VIS-DISK STREP-A (EIA) (August 15, 1989)
  • K891096 — VIS-DISK HCG (EIA) JPL-041M (June 16, 1989)
  • K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M (June 16, 1989)
  • K880577 — CONCEP-7-BHCG (March 15, 1988)
  • K880069 — LEECO PREGNASTICK (EIA) CATALOG #003 (February 11, 1988)
  • K870259 — VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (March 10, 1987)
  • K864170 — LEECO VIS-CUBE STREP A (EIA) (February 3, 1987)
  • K863999 — VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (January 9, 1987)
  • K863933 — VIS-CUBE HCG (EIA) (December 15, 1986)

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)
  • K944698 — AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (March 21, 1995)