NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
FDA 510(k) clearance K900009 · decided 1990-03-29
Clearance details
- K-number
- K900009
- Device name
- NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET
- Applicant
- Kallestad Diag, A Div. of Erbamont, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-02
- Decision date
- 1990-03-29
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- KLS
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.