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510(k) K853865

PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO by Pantex, Div. Bio-Analysis, Inc. — Product Code CDZ

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, Testosterones And Dihydrotestosterone
Device Class
Class I
Regulation Number
862.1680
Review Panel
CH
Submission Type

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

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  • 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)

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