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510(k) K912026

DELFIA(R) 17 -OH-PROGESTERON KIT by Pharmacia Diagnostics, Inc. — Product Code JLX

K912026 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics, Inc. for the device "DELFIA(R) 17 -OH-PROGESTERON KIT". The FDA issued a decision of Substantially Equivalent on June 25, 1991. The device falls under product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone), a Class I device regulated under 21 CFR 862.1395. Pharmacia Diagnostics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1991
Date Received
May 7, 1991
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 Pharmacia Diagnostics, Inc.

  • K052793 — IMMUNOCAP/UNICAP GLIADIN IGA, IMMUNOCAP/UNICAP SPECIFIC IGA, MODELS 14-4425-40, (February 7, 2006)
  • K051218 — MODIFICATION TO: UNICAP SPECIFIC IGE (June 9, 2005)
  • K921011 — PHARMACIA CMV IGM ELISA (July 27, 1992)
  • K920702 — TOXOPLASMA GONDII (TOXO) IGM ENZYME-LINKED IMMUNO (July 8, 1992)
  • K915348 — EBV-VCA IGM ELISA (February 14, 1992)
  • K914022 — SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS (January 27, 1992)
  • K902793 — RUBELLA IGG (July 31, 1990)
  • K902792 — TOXOPLASMA GONDII IGG (July 24, 1990)

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