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510(k) K920921

ELISA TUBE PROLACTIN TEST KIT by Bio Clinic Co. — Product Code CFT

K920921 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "ELISA TUBE PROLACTIN TEST KIT". The FDA issued a decision of Substantially Equivalent on April 8, 1992. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Bio Clinic Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1992
Date Received
February 28, 1992
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 Bio Clinic Co.

  • K930791 — AMERICAN POWER CONVERSIONS, BACK-UPS 600 (August 6, 1993)
  • K932480 — PRISM (July 21, 1993)
  • K926189 — ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE (June 24, 1993)
  • K921958 — ELISA TUBE TSH TEST (July 2, 1992)
  • K922140 — ORTHODERM CONVERTIBLE II (May 27, 1992)
  • K921212 — MIRCO ELISA HPL TEST KIT (May 7, 1992)
  • K921211 — NOW PREGNANCY TEST KIT (May 7, 1992)
  • K920920 — ELISA TUBE LH TEST KIT (April 8, 1992)
  • K920918 — TMB CHROMOGEN/SUBSTRATE REAGENT SET (April 7, 1992)
  • K920917 — ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY (March 26, 1992)

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