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510(k) K905769

IMMULITE HS-TSH by Cirrus Diagnostics, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1991
Date Received
December 27, 1990
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 Cirrus Diagnostics, Inc.

  • K921704 — IMMULITE(R) FSH (June 9, 1992)
  • K920411 — IMMULITE HLH (March 11, 1992)
  • K914833 — IMMULITE DIGOXIN (November 22, 1991)
  • K911796 — IMMULITE(TM) HCG (June 20, 1991)
  • K910677 — IMMULITE(TM) T-UPTAKE (April 29, 1991)
  • K910261 — IMMULITE(TM) TOTAL T4 (April 16, 1991)
  • K905648 — CRP LIPID REAGENT TEST PACK (March 6, 1991)
  • K905214 — IMMULITE (TM) TOTAL T3 (February 1, 1991)
  • K905215 — IMMULITE (TM) AUTOMATED IMMUNOASSAY ANALYZER (January 11, 1991)

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