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510(k) K852438

NML TSH IRMA by Nuclear Medical Laboratories, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1985
Date Received
June 10, 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 Nuclear Medical Laboratories, Inc.

  • K844583 — TSH-STAT (March 5, 1985)
  • K840466 — NML CORTISOL RIA (March 30, 1984)
  • K840589 — TRI-TUBE RIA (March 9, 1984)
  • K832892 — MODIFIED CHORIO-SHURE (October 28, 1983)
  • K832002 — NML-5010/5020 MULTI-DETECTOR SYSTEM (August 8, 1983)
  • K823679 — NML 6000 CT (January 7, 1983)
  • K823053 — NML-TETRA-TUBE RIA (November 10, 1982)
  • K822298 — DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (September 2, 1982)
  • K820523 — CHORIO-QUANT (March 15, 1982)
  • K812759 — NML CK-MB RIA (October 19, 1981)

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