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510(k) K934178

ACCUSCREEN 17-HYDROXYPROGESTERONE by Neometrics, Inc. — Product Code JLX

K934178 is an FDA 510(k) premarket notification submitted by Neometrics, Inc. for the device "ACCUSCREEN 17-HYDROXYPROGESTERONE". The FDA issued a decision of Substantially Equivalent on March 30, 1995. The device falls under product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone), a Class I device regulated under 21 CFR 862.1395. Neometrics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 1995
Date Received
August 27, 1993
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 Neometrics, Inc.

  • K152560 — Bard Snare Retrieval Kit (October 23, 2015)
  • K150225 — NovaGold High Performance Guidewire (March 16, 2015)
  • K143135 — Spring Coil Guidewire (February 20, 2015)
  • K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (February 20, 2014)
  • K123439 — NEO ERCP GUIDEWIRE (January 3, 2013)
  • K101729 — NEOWIRE PTA/PTCA GUIDEWIRE (September 23, 2010)
  • K070150 — VASCUPUNCTURE PICC GUIDEWIRE (February 15, 2007)
  • K043398 — MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE (March 1, 2005)
  • K040786 — VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING (April 19, 2004)
  • K033321 — SELECTIVA SB GUIDEWIRE (November 5, 2003)

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)
  • 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)
  • K940233 — NEOSCREEN ELISA HYDROXYPROGESTERONE (December 28, 1994)
  • K943148 — DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) (November 10, 1994)

FDA data resources