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510(k) K853977

BETA-TSH-IRMA by Leeco Diagnostics, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1985
Date Received
September 26, 1985
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 Leeco Diagnostics, Inc.

  • K895765 — LEECO PREVIEW(R) EBV (EIA) (October 31, 1989)
  • K894122 — LEECO VIS-DISK STREP-A (EIA) (August 15, 1989)
  • K891095 — VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M (June 16, 1989)
  • K891096 — VIS-DISK HCG (EIA) JPL-041M (June 16, 1989)
  • K883269 — PRL-QUANT (September 13, 1988)
  • K880577 — CONCEP-7-BHCG (March 15, 1988)
  • K880069 — LEECO PREGNASTICK (EIA) CATALOG #003 (February 11, 1988)
  • K870259 — VIS-CUBE HCG (EIA) LYOPHILIZED JPL-044 (March 10, 1987)
  • K864170 — LEECO VIS-CUBE STREP A (EIA) (February 3, 1987)
  • K863999 — VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 (January 9, 1987)

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