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510(k) K011525

SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) by Biosafe Laboratories, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2001
Date Received
May 17, 2001
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 Biosafe Laboratories, Inc.

  • K042379 — ANEMIAPRO SELF-SCREENER (December 15, 2004)
  • K012221 — SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (April 3, 2002)
  • K011970 — BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (September 26, 2001)
  • K003752 — BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (March 23, 2001)
  • K991850 — SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC (November 26, 1999)

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