UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
FDA 510(k) clearance K013371 · decided 2001-12-21
Clearance details
- K-number
- K013371
- Device name
- UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
- Applicant
- Otsuka Pharmaceutical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-11
- Decision date
- 2001-12-21
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- JJQ
- Device class
- 1
- Regulation number
- 862.2300
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| UBiT-IR300 Infrared Spectrophotometer, Software Versions 7.0, 7.01 and 7.11. recall (Z-1749-2008) | Otsuka America Pharmaceutical, Inc. | 2008-09-01 |