HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT— 510(k) K992845
Substantially EquivalentElan Holdings, Inc.
FDA 510(k) clearance K992845 for HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT, Substantially Equivalent on 1999-10-18. Applicant: Elan Holdings, Inc.. Device class: 2.
Clearance details
- Applicant
- Elan Holdings, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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More clearances from Elan Holdings, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.