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510(k) K911839

NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT by Pantex, Div. Bio-Analysis, Inc. — Product Code JLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1991
Date Received
April 25, 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

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Other clearances for product code JLX

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  • 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)
  • K934178 — ACCUSCREEN 17-HYDROXYPROGESTERONE (March 30, 1995)
  • K940233 — NEOSCREEN ELISA HYDROXYPROGESTERONE (December 28, 1994)