MODELS IDA-2 PLUS AND IPT-1
FDA 510(k) clearance K961862 · decided 1997-02-26
Clearance details
- K-number
- K961862
- Device name
- MODELS IDA-2 PLUS AND IPT-1
- Applicant
- Bio-Tek Instruments, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1996-05-14
- Decision date
- 1997-02-26
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Winooski, VT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.