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510(k) K963498

FERR FLEX REAGENT CARTRIDGE by Dade Chemistry Systems, Inc. — Product Code JMG

K963498 is an FDA 510(k) premarket notification submitted by Dade Chemistry Systems, Inc. for the device "FERR FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on January 24, 1997. The device falls under product code JMG (Radioimmunoassay (Two-Site Solid Phase), Ferritin), a Class II device regulated under 21 CFR 866.5340. Dade Chemistry Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1997
Date Received
September 3, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device Class
Class II
Regulation Number
866.5340
Review Panel
CH
Submission Type

Other clearances by Dade Chemistry Systems, Inc.

  • K973650 — TROPONIN (TROP) METHOD (October 20, 1997)
  • K973099 — PROSTATE SPECIFIC ANTIGEN CONTROL (September 29, 1997)
  • K973100 — PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR (September 29, 1997)
  • K973101 — PROSTATE SPECIFIC ANTIGEN METHOD (September 18, 1997)
  • K971141 — FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM (April 28, 1997)
  • K970387 — HUMAN CHORIONIC GONADOTROPIN METHOD (March 10, 1997)
  • K970393 — THYROID STIMULATING HORMONE METHOD (March 3, 1997)
  • K970336 — MMB CALIBRATOR (March 3, 1997)
  • K970396 — HUMAN CHORIONIC GONADOTROPIN CALIBRATOR (February 20, 1997)
  • K970389 — THYROID CALIBRATOR (February 18, 1997)

Other clearances for product code JMG

  • K234052 — Access Ferritin (March 20, 2024)
  • K052082 — FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (August 19, 2005)
  • K964282 — TINA-QUANT FERRITIN ASSAY (July 30, 1997)
  • K971833 — ELECSYS FERRITIN (June 2, 1997)
  • K950393 — ACE(TM) CEDIA(R) FERRITIN ASSAY (May 16, 1995)
  • K925848 — IMMULITE FERRITIN (January 13, 1993)
  • K926221 — ACCESS FERRITIN ASSAY (January 13, 1993)
  • K920829 — COBAS CORE FERRITIN EIA (June 19, 1992)
  • K920318 — CEDIA FERRITIN ASSAY (June 4, 1992)
  • K902997 — MILENIA (TM) FERRITIN (August 2, 1990)

FDA data resources