The following data is part of a premarket notification filed by Lincoln Diagnostics, Inc. with the FDA for Multi-test Ii.
Device ID | K961918 |
510k Number | K961918 |
Device Name: | MULTI-TEST II |
Classification | System, Delivery, Allergen And Vaccine |
Applicant | LINCOLN DIAGNOSTICS, INC. HICKORY POINT RD BOX 1128 Decatur, IL 62525 |
Contact | Gary L Heni |
Correspondent | Gary L Heni 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 | 1996-05-17 |
Decision Date | 1996-08-07 |