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510(k) K971921

PROLACTIN (PRL) HORMONE MICROPLATE ELISA by Monobind — Product Code CFT

K971921 is an FDA 510(k) premarket notification submitted by Monobind for the device "PROLACTIN (PRL) HORMONE MICROPLATE ELISA". The FDA issued a decision of Substantially Equivalent on June 24, 1997. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Monobind has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1997
Date Received
May 23, 1997
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

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  • K063437 — ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 (April 4, 2008)
  • K030860 — ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300 (August 22, 2003)
  • K020548 — FREE T4 (THYTOXINE) MICROPLATE EIA TEST MODELS # 1225-300 (April 5, 2002)
  • K980088 — T-UPTAKE MICROPLATE EIA (February 4, 1998)
  • K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) (September 2, 1997)
  • K971835 — ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA (July 3, 1997)
  • K971834 — ANTI-THYROID PEROXIDASE (TPO) MICROPLATE ELISA (July 3, 1997)
  • K971780 — THYROTROPIN(TSH) ELISA (June 24, 1997)
  • K971779 — TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA (June 16, 1997)

Other clearances for product code CFT

  • 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)
  • K943811 — ENZYME-LINKED FLUORESCENT IMMUNOASSAY (November 2, 1994)

FDA data resources