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510(k) K903391

ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM by Nichols Institute — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1990
Date Received
July 27, 1990
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

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  • K950524 — NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY (May 15, 1995)
  • K932650 — ERYTHROPOIETIN IMMUNOASSAY KIT (March 11, 1994)
  • K931600 — CHEMILUMINESCENCE FREE T3 IMMUNOASSAY (September 8, 1993)
  • K931777 — APO A-1 CHEMILUMINESCENCE ASSAY (August 16, 1993)
  • K926396 — ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT (July 27, 1993)
  • K931601 — CHEMILUMINESCENCE DHEA-S IMMUNOASSAY (July 27, 1993)
  • K931311 — THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT (May 14, 1993)

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