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510(k) K944490

AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT by Wallac OY — Product Code CGI

K944490 is an FDA 510(k) premarket notification submitted by Wallac OY for the device "AUTODELFIA UNCONJUGATED ESTRIOL (UE3) KIT". The FDA issued a decision of Substantially Equivalent on December 9, 1994. The device falls under product code CGI (Radioimmunoassay, Estriol), a Class I device regulated under 21 CFR 862.1265. Wallac OY has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1994
Date Received
September 13, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estriol
Device Class
Class I
Regulation Number
862.1265
Review Panel
CH
Submission Type

Other clearances by Wallac OY

  • DEN140010 — PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (December 15, 2014)
  • K131284 — GSP NEONATAL BIOTINIDASE KIT (November 14, 2013)
  • K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (July 23, 2010)
  • K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (April 16, 2009)
  • K071649 — NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND (August 7, 2008)
  • K070889 — AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 (April 14, 2008)
  • K050709 — RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, (March 8, 2006)
  • K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (July 11, 2005)
  • K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)

Other clearances for product code CGI

  • K974721 — UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SY (March 3, 1998)
  • K962875 — ACTIVE ULTRASENSITIVE UNCONJUGATED ESTRIOL EIA (August 23, 1996)
  • K955356 — ACTIVE ULTRA-SENSITIVE UNCONJUGATED ESTRIOL (May 15, 1996)
  • K932989 — COAT-A-COUNT FREE ESTRIOL (December 19, 1994)
  • K920576 — AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL (March 23, 1992)
  • K903359 — MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT (August 22, 1990)
  • K860900 — IMMPULSE FREE ESTRIOL ASSAY REAGENTS (April 28, 1986)
  • K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (March 26, 1985)
  • K844767 — RADIOIMMUNOASSAY OF HUMAN SERUM PLASMA OR URINE TO (February 1, 1985)
  • K844511 — TDX TOTAL ESTRIOL (January 18, 1985)

FDA data resources