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510(k) K012221

SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM by Biosafe Laboratories, Inc. — Product Code JKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2002
Date Received
July 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Biosafe Laboratories, Inc.

  • K042379 — ANEMIAPRO SELF-SCREENER (December 15, 2004)
  • K011970 — BIOSAFE CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM (September 26, 2001)
  • K011525 — SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYS (July 16, 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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