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510(k) K953656

ABBOTT IMX PROLACTIN(MODIFICATION) by Abbott Mfg., Inc. — Product Code CFT

K953656 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "ABBOTT IMX PROLACTIN(MODIFICATION)". The FDA issued a decision of Substantially Equivalent on October 3, 1995. The device falls under product code CFT (Radioimmunoassay, Prolactin (Lactogen)), a Class I device regulated under 21 CFR 862.1625. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1995
Date Received
July 18, 1995
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 Abbott Mfg., Inc.

  • K981457 — ALBP (May 27, 1998)
  • K981232 — CA (May 18, 1998)
  • K981231 — CO2 (May 12, 1998)
  • K965230 — ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP (July 3, 1997)
  • K971293 — LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE (June 27, 1997)
  • K953657 — ABBOTT AXSYM PROLACTIN(MODIFICATION) (September 25, 1995)
  • K944669 — FLEXIFLO QUANTUM ENTERAL PUMP (July 24, 1995)
  • K943691 — IMX FOLATE (March 23, 1995)
  • K943733 — FLEXIFLO SIX ENTERAL NUTRITION PUMP (December 12, 1994)
  • K941214 — LIFESHIELD EXTENSION SET (October 3, 1994)

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)
  • 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