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510(k) K860823

ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT by Cis-Us, Inc. — Product Code CFT

K860823 is an FDA 510(k) premarket notification submitted by Cis-Us, Inc. for the device "ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT". The FDA issued a decision of Substantially Equivalent on August 19, 1986. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Cis-Us, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
March 4, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Prolactin (Lactogen)
Device Class
Class I
Regulation Number
862.1625
Review Panel
CH
Submission Type

Other clearances by Cis-Us, Inc.

  • K951708 — ELSA-HCT (September 5, 1995)
  • K950211 — ELSA-PTH (April 13, 1995)
  • K890799 — CURIETRON 192 HIGH DOSE RATE (October 27, 1989)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K871502 — PERSONNEL PROTECTIVE SHIELD (May 8, 1987)
  • K865027 — IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C (February 26, 1987)
  • K863778 — VENTICIS II (October 27, 1986)
  • K860824 — TSHK-NN RIA KIT (April 28, 1986)

Other clearances for product code CFT

  • K971921 — PROLACTIN (PRL) HORMONE MICROPLATE ELISA (June 24, 1997)
  • K970281 — VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS (February 25, 1997)
  • K970188 — SEALITE SCIENCES, INC. AQUALITE PROLACTIN (February 20, 1997)
  • K964748 — ELECSYS PROLACTIN ASSAY (January 21, 1997)
  • K960561 — DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 (April 26, 1996)
  • K960060 — DSL ACTIVE PROLACTIN IRMA (February 29, 1996)
  • K954680 — ACCESS PROLACTIN ASSAY (MODIFICATION) (October 20, 1995)
  • K953656 — ABBOTT IMX PROLACTIN(MODIFICATION) (October 3, 1995)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K944698 — AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 (March 21, 1995)

FDA data resources