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Avl 9181 Electrolyte Analyzer

by Avl Scientific Corp. 510(k)

Active United States

510(k) K972673

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972673 Date20 Aug 1997ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0610-05 FDA Unclassified (pre-2012) initiated 21 Dec 2004 via K972673, on the same 510(k)
    • Terminated Z-0611-05 FDA Unclassified (pre-2012) initiated 21 Dec 2004 via K972673, on the same 510(k)
    • Terminated Z-0608-05 FDA Unclassified (pre-2012) initiated 21 Dec 2004 via K972673, on the same 510(k)
    • Terminated Z-0609-05 FDA Unclassified (pre-2012) initiated 21 Dec 2004 via K972673, on the same 510(k)
    • Terminated Z-0605-05 FDA Unclassified (pre-2012) initiated 21 Dec 2004 via K972673, on the same 510(k)
    • Terminated Z-0606-05 FDA Unclassified (pre-2012) initiated 21 Dec 2004 via K972673, on the same 510(k)
    • Terminated Z-0607-05 FDA Unclassified (pre-2012) initiated 21 Dec 2004 via K972673, on the same 510(k)

    A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
JFP
Device Class
Class II
Regulation
21 CFR Part 862.1145
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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