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510(k) K781733

RIA KIT, PREG-STAT by Serono Laboratories, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
October 13, 1978
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 Serono Laboratories, Inc.

  • K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (March 2, 1984)
  • K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT (March 31, 1981)
  • K810625 — HUMAN PLACENTAL LACTOGEN RADIOIMMUNO- (March 27, 1981)
  • K792043 — PAP-CHECK RIA KIT (October 30, 1979)
  • K790679 — ESTRADIOL RIA KIT (May 23, 1979)
  • K790440 — PROGESTERONE (May 3, 1979)
  • K782143 — RIA KIT, GLUCOSE (February 22, 1979)
  • K782103 — RIA KIT, NEONATAL T4 (January 17, 1979)
  • K781285 — INSULIN RIA KIT (August 14, 1978)

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