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510(k) K823679

NML 6000 CT by Nuclear Medical Laboratories, Inc. — Product Code JQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1983
Date Received
December 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator/Data Processing Module, For Clinical Use
Device Class
Class I
Regulation Number
862.2100
Review Panel
CH
Submission Type

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  • K840589 — TRI-TUBE RIA (March 9, 1984)
  • K832892 — MODIFIED CHORIO-SHURE (October 28, 1983)
  • K832002 — NML-5010/5020 MULTI-DETECTOR SYSTEM (August 8, 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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