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510(k) K810625

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

K810625 is an FDA 510(k) premarket notification submitted by Serono Laboratories, Inc. for the device "HUMAN PLACENTAL LACTOGEN RADIOIMMUNO-". The FDA issued a decision of Substantially Equivalent on March 27, 1981. The device falls under product code DHI (Ng3m(Bo), Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5065. Serono Laboratories, Inc. has at least 9 other 510(k) clearances on record.

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

Other clearances by Serono Laboratories, Inc.

  • K834428 — ALDOSTERONE RADIOIMMUNOASSAY TEST KIT (March 2, 1984)
  • K810695 — ESTRIOL RADIOIMMUNOASSAY TEST KIT (March 31, 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)
  • K781733 — RIA KIT, PREG-STAT (December 20, 1978)
  • K781285 — INSULIN RIA KIT (August 14, 1978)

FDA data resources