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510(k) K930006

AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT by Bio-Chem Laboratory Systems, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1993
Date Received
January 4, 1993
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 Bio-Chem Laboratory Systems, Inc.

  • K945271 — ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM (April 20, 1995)
  • K930689 — AUTOBEAD THYROID UPTAKE (November 10, 1993)
  • K926563 — AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT (March 18, 1993)
  • K924084 — ATAC 6000 CHEMISTRY ANALYZER (September 29, 1992)

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