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510(k) K810695

ESTRIOL RADIOIMMUNOASSAY TEST KIT by Serono Laboratories, Inc. — Product Code CHP

K810695 is an FDA 510(k) premarket notification submitted by Serono Laboratories, Inc. for the device "ESTRIOL RADIOIMMUNOASSAY TEST KIT". The FDA issued a decision of Substantially Equivalent on March 31, 1981. The device falls under product code CHP (Radioimmunoassay, Estradiol), a Class I device regulated under 21 CFR 862.1260. Serono Laboratories, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1981
Date Received
March 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Estradiol
Device Class
Class I
Regulation Number
862.1260
Review Panel
CH
Submission Type

Other clearances by Serono Laboratories, Inc.

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

Other clearances for product code CHP

  • K041349 — LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM (September 24, 2004)
  • K973901 — 17 B-ESTRADIOL (ELISA) (November 24, 1997)
  • K973743 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (October 31, 1997)
  • K970386 — ACS ESTADIOL-6 II (June 4, 1997)
  • K970643 — VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CA (March 18, 1997)
  • K970126 — ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545) (February 25, 1997)
  • K965109 — ELECSYS ESTRADIOL ASSAY (February 18, 1997)
  • K955647 — VIDAS ESTRADIOL II (E2II) ASSAY (February 6, 1996)
  • K954697 — CIBA CORNING ACS ESTRADIOL-6 ASSAY (December 13, 1995)
  • K953605 — ULTRA-SENSITIVE ESTRADIOL (October 2, 1995)

FDA data resources