DUOTIP-TEST
System, Delivery, Allergen And Vaccine
LINCOLN DIAGNOSTICS, INC.
The following data is part of a premarket notification filed by Lincoln Diagnostics, Inc. with the FDA for Duotip-test.
Pre-market Notification Details
| Device ID | K941820 |
| 510k Number | K941820 |
| Device Name: | DUOTIP-TEST |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | LINCOLN DIAGNOSTICS, INC. HICKORY POINT RD BOX 1128 Decatur, IL 62525 |
| Contact | Gary L Hein |
| Correspondent | Gary L Hein LINCOLN DIAGNOSTICS, INC. HICKORY POINT RD BOX 1128 Decatur, IL 62525 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-13 |
| Decision Date | 1994-09-02 |
Trademark Results [DUOTIP-TEST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUOTIP-TEST 74381634 1896898 Live/Registered |
Lincoln Diagnostics, Inc. 1993-04-19 |
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