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510(k) K050960

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT by Wallac OY — Product Code JLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2005
Date Received
April 18, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, 17-Hydroxyprogesterone
Device Class
Class I
Regulation Number
862.1395
Review Panel
CH
Submission Type

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  • K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K003664 — DELFIA NEONATAL IRT KIT, MODEL A005-110 (February 14, 2001)

Other clearances for product code JLX

  • K100682 — GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U (July 23, 2010)
  • K081922 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (April 16, 2009)
  • K062534 — ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE (January 29, 2008)
  • K060452 — ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH (March 13, 2007)
  • K042424 — DELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K042425 — AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (September 30, 2004)
  • K973350 — BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST (February 9, 1998)
  • K934178 — ACCUSCREEN 17-HYDROXYPROGESTERONE (March 30, 1995)
  • K940233 — NEOSCREEN ELISA HYDROXYPROGESTERONE (December 28, 1994)
  • K943148 — DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) (November 10, 1994)