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510(k) K060452

ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH by Neo-Genesis — Product Code JLX

K060452 is an FDA 510(k) premarket notification submitted by Neo-Genesis for the device "ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH". The FDA issued a decision of Substantially Equivalent on March 13, 2007. The device falls under product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone), a Class I device regulated under 21 CFR 862.1395.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2007
Date Received
February 21, 2006
Clearance Type
Abbreviated
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

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)
  • K050960 — MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT (July 11, 2005)
  • 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)

FDA data resources