The following data is part of a premarket notification filed by Bio-tek Instruments, Inc. with the FDA for Models Ida-2 Plus And Ipt-1.
| Device ID | K961862 |
| 510k Number | K961862 |
| Device Name: | MODELS IDA-2 PLUS AND IPT-1 |
| Classification | Pump, Infusion |
| Applicant | BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Contact | Michael N Sevigny |
| Correspondent | Michael N Sevigny BIO-TEK INSTRUMENTS, INC. HIGHLAND PARK P.O. BOX 998 Winooski, VT 05404 -0998 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-14 |
| Decision Date | 1997-02-26 |
| Summary: | summary |