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510(k) K853867

PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY by Pantex, Div. Bio-Analysis, Inc. — Product Code JKC

K853867 is an FDA 510(k) premarket notification submitted by Pantex, Div. Bio-Analysis, Inc. for the device "PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on October 4, 1985. The device falls under product code JKC (Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)), a Class I device regulated under 21 CFR 862.1245. Pantex, Div. Bio-Analysis, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1985
Date Received
September 17, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device Class
Class I
Regulation Number
862.1245
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 JKC

  • K040181 — ACCESS DHEA-S REAGENT ASSAY (March 24, 2004)
  • K003174 — ELECSYS DHEA-S (January 17, 2001)
  • K973897 — DHEA-S (November 13, 1997)
  • K962895 — DSL DHEA-S-7 (September 10, 1996)
  • K955114 — DSL AACTIVE DHEA EIA KIT (February 23, 1996)
  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K935014 — ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000) (May 9, 1994)
  • K935806 — IMMULITE DHEA-S04 (April 26, 1994)
  • K935469 — SYNELISA DHEA-SULFATE (March 22, 1994)

FDA data resources