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510(k) K822241

FOLATE/B12 DUO-BEAD RADIOASSAY by Abbott Laboratories — Product Code CEN

K822241 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "FOLATE/B12 DUO-BEAD RADIOASSAY". The FDA issued a decision of Substantially Equivalent on October 26, 1982. The device falls under product code CEN (Dye-Indicator, Ph (Urinary, Non-Quantitative)), a Class I device regulated under 21 CFR 862.1550. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1982
Date Received
July 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

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Other clearances for product code CEN

  • K091287 — VS-SENSE TEST (August 31, 2009)
  • K071100 — AMNISCREEN HOME DETECTION LINER KIT (October 15, 2007)
  • K051727 — AIMSTICK URINE REAGENT STRIPS (October 26, 2005)
  • K040008 — QUICKVUE ADVANCE PH AND AMINES GLL TEST (April 29, 2004)
  • K030650 — STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS (April 14, 2003)
  • K962718 — FEMEXAM TESTCARD (February 7, 1997)
  • K840827 — KYOTEST 5V (May 14, 1984)
  • K830824 — URINE SCREENING KIT (June 12, 1983)
  • K830979 — HELENA BIOSTRIP PH (May 5, 1983)
  • K830091 — LITH A TEST TM (February 15, 1983)

FDA data resources