Home / 510(k) Clearances / K853866

510(k) K853866

PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS by Pantex, Div. Bio-Analysis, Inc. — Product Code CHP

K853866 is an FDA 510(k) premarket notification submitted by Pantex, Div. Bio-Analysis, Inc. for the device "PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS". The FDA issued a decision of Substantially Equivalent on October 15, 1985. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Pantex, Div. Bio-Analysis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1985
Date Received
September 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estradiol
Device Class
Class I
Regulation Number
862.1260
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)
  • K894049 — IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT (September 8, 1989)
  • K862483 — PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT (January 14, 1987)
  • K862447 — PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT (October 7, 1986)

Other clearances for product code CHP

  • K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (September 24, 2004)
  • K973901 — 17 B-ESTRADIOL (ELISA) (November 24, 1997)
  • K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)
  • K970386 — ACS ESTADIOL-6 II (June 4, 1997)
  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (March 18, 1997)
  • K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (February 25, 1997)
  • K965109 — ELECSYS ESTRADIOL ASSAY (February 18, 1997)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K954697 — CIBA CORNING ACS ESTRADIOL-6 ASSAY (December 13, 1995)
  • K953605 — ULTRA-SENSITIVE ESTRADIOL (October 2, 1995)

FDA data resources