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510(k) K874622

FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 by Cyberfluor, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1987
Date Received
November 10, 1987
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 Cyberfluor, Inc.

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  • K900621 — FIAGEN(TM) HLH.S (March 1, 1990)
  • K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-402 (November 8, 1989)
  • K895396 — CYBERFLUOR FIAGEN TSH (October 31, 1989)
  • K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
  • K883182 — FIAGEN RUBELLA IGG (October 31, 1988)

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