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510(k) K894049

IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT by Pantex, Div. Bio-Analysis, Inc. — Product Code JLS

K894049 is an FDA 510(k) premarket notification submitted by Pantex, Div. Bio-Analysis, Inc. for the device "IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on September 8, 1989. The device falls under product code JLS (Radioimmunoassay, Progesterone), a Class I device regulated under 21 CFR 862.1620. Pantex, Div. Bio-Analysis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1989
Date Received
June 7, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Progesterone
Device Class
Class I
Regulation Number
862.1620
Review Panel
CH
Submission Type

Other clearances by Pantex, Div. Bio-Analysis, Inc.

  • K102841 — PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY (May 8, 2012)
  • K942658 — NEOSCREEN ELISA TSH (February 24, 1995)
  • K914107 — PROLACTIN IRMA IMMUNOMAG (September 30, 1991)
  • K912804 — FSH IRMA IMMUNOMAG (August 12, 1991)
  • K911839 — NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT (June 18, 1991)
  • K911050 — LH IRMA IMMUNOMAG (April 12, 1991)
  • K910717 — PANTEX IRMA LH 1251 KIT (March 19, 1991)
  • K862483 — PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (January 14, 1987)
  • K862447 — PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT (October 7, 1986)
  • K862336 — PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT (September 25, 1986)

Other clearances for product code JLS

  • K040923 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA (July 22, 2004)
  • K973898 — PROGESTERONE ELISA (November 13, 1997)
  • K972133 — VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTE (June 24, 1997)
  • K971725 — OPUS PROGESTERONE (June 18, 1997)
  • K964841 — ELECSYS PROGESTERONE ASSAY (March 24, 1997)
  • K965084 — VIDAS PROESTERONE (PRG) (30 409) (January 9, 1997)
  • K955025 — AXSYM PROGESTERONE (March 7, 1996)
  • K955769 — ACCESS PROGESTERONE ASSAY (February 5, 1996)
  • K952075 — PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM (June 13, 1995)
  • K951630 — AURAFLEX PROGESTERONE 150TEST PACK (May 8, 1995)

FDA data resources