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510(k) K911050

LH IRMA IMMUNOMAG by Pantex, Div. Bio-Analysis, Inc. — Product Code CEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1991
Date Received
March 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Luteinizing Hormone
Device Class
Class I
Regulation Number
862.1485
Review Panel
CH
Submission Type

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  • K862447 — PANCOAT T3 UPTAKE COATED TUBE RADIOIMMUNOASSAY KIT (October 7, 1986)
  • K862336 — PANCOAT CORTISOL COATED TUBE RADIOIMMUNOASSAY KIT (September 25, 1986)

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