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510(k) K792443

TSH RADIOIMMUNOASSAY by Dade, Baxter Travenol Diagnostics, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1979
Date Received
November 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Dade, Baxter Travenol Diagnostics, Inc.

  • K800296 — WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3 (March 5, 1980)
  • K792606 — WHOLE BLOOD PLATELET CONTROL NORMAL, (February 13, 1980)
  • K792723 — BLOOD FLUID FILTERS (January 21, 1980)
  • K792607 — T3 UPTAKE (T3U) REAGENTS (January 16, 1980)
  • K792442 — FERRITIN RADIOIMMUNOASSAY (December 18, 1979)
  • K791922 — HARLECO BRAND CLINICARD LIPASE TEST SET (November 27, 1979)
  • K792183 — DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO (November 13, 1979)
  • K790767 — IMMU-TEK AUTOMATIC CENTRIFUGE (May 23, 1979)
  • K790776 — DADE LOW IONIC STRENGTH SOLUITION (LISS) (May 23, 1979)
  • K790571 — QUIK-STAIN (April 23, 1979)

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  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
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