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510(k) K885198

17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA by Icn Biomedicals, Inc. — Product Code JLX

K885198 is an FDA 510(k) premarket notification submitted by Icn Biomedicals, Inc. for the device "17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA". The FDA issued a decision of Substantially Equivalent on February 23, 1989. The device falls under product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone), a Class I device regulated under 21 CFR 862.1395. Icn Biomedicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1989
Date Received
December 16, 1988
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 by Icn Biomedicals, Inc.

  • K030211 — RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 (June 13, 2003)
  • K023252 — RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 (November 22, 2002)
  • K926106 — IMMUCHEM PHE-MW EA (February 8, 1995)
  • K922944 — IMMUCHEM LH-MW ELISA (February 2, 1993)
  • K922715 — IMMUCHEM PRL-MW ELISA (October 5, 1992)
  • K922376 — ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT (October 5, 1992)
  • K920442 — IMMUCHEM TSH-MW ELISA (March 18, 1992)
  • K913963 — IMMUCHEM NEONATAL TSH-MP ELISA (December 13, 1991)
  • K902445 — LYMPHO SEP(TM) (August 22, 1990)
  • K881005 — IMMUCHEM HUMAN CHORIONIC GONADOTROPIN HORMONE HCG (May 27, 1988)

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)
  • K940233 — NEOSCREEN ELISA HYDROXYPROGESTERONE (December 28, 1994)

FDA data resources