The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Quintest.
Device ID | K953939 |
510k Number | K953939 |
Device Name: | QUINTEST |
Classification | System, Delivery, Allergen And Vaccine |
Applicant | BAYER CORP. 3525 NORTH REGAL ST. Spokane, WA 99207 |
Contact | David L Mirabell |
Correspondent | David L Mirabell BAYER CORP. 3525 NORTH REGAL ST. Spokane, WA 99207 |
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 | 1995-08-15 |
Decision Date | 1995-11-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00365044000073 | K953939 | 000 |
00365044000066 | K953939 | 000 |
00365044000059 | K953939 | 000 |
10365044000049 | K953939 | 000 |
10365044000032 | K953939 | 000 |
10365044000025 | K953939 | 000 |
10365044000018 | K953939 | 000 |
10365044000001 | K953939 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
QUINTEST 75163413 2419386 Dead/Cancelled |
FERNBANK ELECTRONIC SYSTEMS LIMITED 1996-09-09 |
QUINTEST 74545762 2012379 Live/Registered |
HOLLISTER-STIER LABORATORIES, LLC 1994-07-05 |