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510(k) K940233

NEOSCREEN ELISA HYDROXYPROGESTERONE by Pantex — Product Code JLX

K940233 is an FDA 510(k) premarket notification submitted by Pantex for the device "NEOSCREEN ELISA HYDROXYPROGESTERONE". The FDA issued a decision of Substantially Equivalent on December 28, 1994. 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
December 28, 1994
Date Received
January 18, 1994
Clearance Type
Traditional
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)
  • K060452 — ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH (March 13, 2007)
  • 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)
  • K973350 — BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST (February 9, 1998)
  • K934178 — ACCUSCREEN 17-HYDROXYPROGESTERONE (March 30, 1995)
  • K943148 — DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) (November 10, 1994)

FDA data resources