Home / 510(k) Clearances / K003752

510(k) K003752

BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) by Biosafe Laboratories, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2001
Date Received
December 5, 2000
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)
  • K011525 — SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYS (July 16, 2001)
  • K991850 — SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC (November 26, 1999)

Other clearances for product code JLW

  • K251543 — Atellica® IM TSH3-Ultra II (TSH3ULII) (February 6, 2026)
  • K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimens (April 25, 2025)
  • K234091 — Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 (July 22, 2024)
  • K233050 — ADVIA Centaur® TSH3-Ultra II (TSH3ULII) (April 4, 2024)
  • K222116 — Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL (July 13, 2023)
  • K221225 — Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer (November 10, 2022)
  • K190773 — Elecsys TSH (April 16, 2019)
  • K170232 — AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer (October 13, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K162698 — MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer (July 14, 2017)