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510(k) K820523

CHORIO-QUANT by Nuclear Medical Laboratories, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1982
Date Received
February 26, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Nuclear Medical Laboratories, Inc.

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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)
  • K823679 — NML 6000 CT (January 7, 1983)
  • K823053 — NML-TETRA-TUBE RIA (November 10, 1982)
  • K822298 — DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (September 2, 1982)
  • K812759 — NML CK-MB RIA (October 19, 1981)

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