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510(k) K842478

PROLACTIN IRMA by Euro-Diagnostics BV — Product Code CFT

K842478 is an FDA 510(k) premarket notification submitted by Euro-Diagnostics BV for the device "PROLACTIN IRMA". The FDA issued a decision of Substantially Equivalent on September 14, 1984. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Euro-Diagnostics BV has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1984
Date Received
June 25, 1984
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 Euro-Diagnostics BV

  • K851332 — BLHI LUTEINIZING HORMONE (July 9, 1985)
  • K851148 — TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE (April 29, 1985)
  • K850053 — BACI 6 -ADRENOCORTICOTROOP HORMONE (April 8, 1985)
  • K843930 — IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I (October 30, 1984)

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)

FDA data resources