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Temperature Probe 06320480210

by Instrumentation Laboratory Company

Temperature Probe 06320480210 is a Class I device made by Instrumentation Laboratory Company, cleared under FDA 510(k) K951485 on 6 Nov 1995 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 08426950452614), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

510(k) K951485

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08426950452614 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK951485 Date6 Nov 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K951485 decided 6 Nov 1995 Active
  • FDA GUDID UDI-DI 08426950452614 listed 23 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2218-2011 FDA Unclassified (pre-2012) initiated 23 Mar 2011 on shared 510(k) K951485

    An incorrect calibration code that affects the total hemoglobin measurement was applied to affected Avoximeter instruments.

    • Terminated Z-1239-2008 FDA Unclassified (pre-2012) initiated 13 Feb 2008

    Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K951485
  2. Recall initiated FDA recalls Z-1239-2008
  3. Recall initiated FDA recalls Z-2218-2011
  4. Listed FDA GUDID 08426950452614

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Temperature Probe
Generic name
Coagulation analyser IVD, laboratory, semi-automated
Model / Ref / Catalog
06320480210
Primary DI / UDI-DI
08426950452614
510(k) Number
FDA product code
JKS
GMDN term
Coagulation analyser IVD, laboratory, semi-automated
Device class
Class I
Regulation number
862.3220
GUDID distribution status
In Commercial Distribution

Related devices

Category: Coagulation analyser IVD, laboratory, semi-automated

Cleared under the same submission (K951485)

and 2 more cleared under K951485

Similar devices

Other devices filed under FDA product code JKS (Spectral absorb. Curve, oxyhemoglobin, carboxyhemoglobin, carbon-monoxide).

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)