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510(k) K810625

HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- by Serono Laboratories, Inc. — Product Code DHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1981
Date Received
March 9, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ng3m(Bo), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5065
Review Panel
IM
Submission Type

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  • K782103 — RIA KIT, NEONATAL T4 (January 17, 1979)
  • K781733 — RIA KIT, PREG-STAT (December 20, 1978)
  • K781285 — INSULIN RIA KIT (August 14, 1978)